Devices and methods for assisting heart function

ABSTRACT

Devices and methods for assisting heart function. In at least one embodiment of a device for assisting heart function, the device comprises at least two electromagnetic plates having an inner surface, a cardiac processor electrically coupled to at least one of the at least two electromagnetic plates, a bladder having an inner chamber, the bladder attached to an inner surface of at least one of the at least two electromagnetic plates, a source of gas in communication with the inner chamber of the bladder, and at least one catheter having a proximal end and a distal end and having a lumen therethrough, the at least one catheter defining at least one aperture positioned therethrough at or near the distal end of the at least one catheter and comprising a pericardial balloon coupled to the at least one catheter at or near the distal end of the at least one catheter, the proximal end of the at least one catheter in communication with the inner chamber of the bladder.

PRIORITY

This U.S. continuation patent application is related to, and claims thepriority benefit of, U.S. Nonprovisional patent application Ser. No.12/596,972, filed Oct. 21, 2009, which is related to, claims thepriority benefit of, and is a U.S. national stage application of,International Patent Application No. PCT/US2008/060870, filed Apr. 18,2008, which (i) claims priority to International Patent Application No.PCT/US2008/053061, filed Feb. 5, 2008, International Patent ApplicationNo. PCT/US2008/015207, filed Jun. 29, 2007, and U.S. Provisional PatentApplication Ser. No. 60/914,452, filed Apr. 27, 2007, and (ii) isrelated to, claims the priority benefit of, and in at least somedesignated countries should be considered a continuation-in-partapplication of, International Patent Application No. PCT/US2008/056666,filed Mar. 12, 2008, which is related to, claims the priority benefitof, and in at least some designated countries should be considered acontinuation-in-part application of, International Patent ApplicationNo, PCT/US2008/053061, filed Feb. 5, 2008, which is related to, claimsthe priority benefit of, and in at least some designated countriesshould be considered a continuation-in-part application of,International Application Serial No. PCT/US2007/015207, filed Jun. 29,2007, which claims priority to U.S. Provisional Patent Application Ser.No. 60/914,452, filed Apr. 27, 2007, and U.S. Provisional PatentApplication Ser. No. 60/817,421, filed Jun. 30, 2006. The contents ofeach of these applications are hereby incorporated by reference in theirentirety into this disclosure.

BACKGROUND

Ischemic heart disease, or coronary heart disease, kills more Americansper year than any other single cause. In 2004, one in every five deathsin the United States resulted from ischemic heart disease. Indeed, thedisease has had a profound impact worldwide. If left untreated, ischemicheart disease can lead to chronic heart failure, which can be defined asa significant decrease in the heart's ability to pump blood. Chronicheart failure is often treated with drug therapy.

Ischemic heart disease is generally characterized by a diminished flowof blood to the myocardium and is also often treated using drug therapy.Although many of the available drugs may be administered systemically,local drug delivery (“LDD”) directly to the heart can result in higherlocal drug concentrations with fewer systemic side effects, therebyleading to improved therapeutic outcomes.

Cardiac drugs may be delivered locally via catheter passing through theblood vessels to the inside of the heart. However, endoluminal drugdelivery has several shortcomings, such as: (1) inconsistent delivery,(2) low efficiency of localization, and (3) relatively rapid washoutinto the circulation.

To overcome such shortcomings, drugs may be delivered, directly into thepericardial space, which surrounds the external surface of the heart.The pericardial space is a cavity formed between the heart and therelatively stiff pericardial sac that encases the heart. Although thepericardial space is usually quite small because the pericardial sac andthe heart are in such close contact, a catheter may be used to inject adrug into the pericardial space for local administration to themyocardial and coronary tissues. Drug delivery methods that supply theagent to the heart via the pericardial space offer several advantagesover endoluminal delivery, including: (1) enhanced consistency and (2)prolonged exposure of the drug to the cardiac tissue.

In current practice, drugs are delivered into the pericardial spaceeither by the percutaneous transventricular method or by thetransthoracic approach. The percutaneous transventricular methodinvolves the controlled penetration of a catheter through theventricular myocardium to the pericardial space. The transthoracicapproach involves accessing the pericardial space from outside the heartusing a sheathed needle with a suction tip to grasp the pericardium,pulling it away from the myocardium to enlarge the pericardial space,and injecting the drug into the space with the needle.

For some patients with chronic heart failure, cardiac resynchronizationtherapy (“CRT”) can be used in addition to drug therapy to improve heartfunction. Such patients generally have an abnormality in conduction thatcauses the right and left ventricles to beat (i.e., begin systole) atslightly different times, which further decreases the heart'salready-limited function. CRT helps to correct this problem ofdyssynchrony by resynchronizing the ventricles, thereby leading toimproved heart function. The therapy involves the use of an implantabledevice that helps control the pacing of at least one of the ventriclesthrough the placement of electrical leads onto specified areas of theheart. Small electrical signals are then delivered to the heart throughthe leads, causing the right and left ventricles to beat simultaneously.

Like the local delivery of drugs to the heart, the placement of CRTleads on the heart can be challenging, particularly when the targetplacement site is the left ventricle. Leads can be placed using atransvenous approach through the coronary sinus, by surgical placementat the epicardium, or by using an endocardial approach. Problems withthese methods of lead placement can include placement at an improperlocation (including inadvertent placement at or near scar tissue, whichdoes not respond to the electrical signals), dissection or perforationof the coronary sinus or cardiac vein during placement, extendedfluoroscopic exposure (and the associated radiation risks) duringplacement, dislodgement of the lead after placement, and long andunpredictable times required for placement (ranging from about 30minutes to several hours).

Clinically, the only approved non-surgical means for accessing thepericardial space include the subxiphoid and the ultrasound-guidedapical and parasternal needle catheter techniques, and each methodsinvolves a transthoracic approach. In the subxiphoid method, a sheathedneedle with a suction tip is advanced from a subxiphoid position intothe mediastinum under fluoroscopic guidance. The catheter is positionedonto the anterior outer surface of the pericardial sac, and the suctiontip is used to grasp the pericardium and pull it away from the hearttissue, thereby creating additional clearance between the pericardialsac and the heart. The additional clearance tends to decrease thelikelihood that the myocardium will be inadvertently punctured when thepericardial sac is pierced.

Although this technique works well in the normal heart, there are majorlimitations in diseased or dilated hearts—the very hearts for which drugdelivery and CRT lead placement are most needed. When the heart isenlarged, the pericardial space is significantly smaller and the risk ofpuncturing the right ventricle or other cardiac structures is increased.Additionally, because the pericardium is a very stiff membrane, thesuction on the pericardium provides little deformation of thepericardium and, therefore, very little clearance of the pericardiumfrom the heart.

As referenced above, the heart is surrounded by a “sac” referred to asthe pericardium. The space between the surface of the heart and thepericardium can normally only accommodate a small amount of fluid beforethe development of cardiac tamponade, defined as an emergency conditionin which fluid accumulates in the pericardium. Therefore, it is notsurprising that cardiac perforation can quickly result in tamponade,which can be lethal. With a gradually accumulating effusion, however, asis often the case in a number of diseases, very large effusions can beaccommodated without tamponade. The key factor is that once the totalintrapericardial volume has caused the pericardium to reach thenoncompliant region of its pressure-volume relation, tamponade rapidlydevelops. Little W. C. and Freeman G. L. (2006). “Pericardial Disease.”Circulation 113(12): 1622-1632.

Cardiac tamponade occurs when fluid accumulation in the intrapericardialspace is sufficient to raise the pressure surrounding the heart to thepoint where cardiac filling is affected. Ultimately, compression of theheart by a pressurized pericardial effusion results in markedly elevatedvenous pressures and impaired cardiac output producing shock which, ifuntreated, it can be rapidly fatal. Id.

The frequency of the different causes of pericardial effusion variesdepending in part upon geography and the patient population, Corey G. R.(2007). “Diagnosis and treatment of pericardial effusion.”http://patients.uptodate.com. A higher incidence of pericardial effusionis associated with certain diseases. For example, twenty-one percent ofcancer patients have metastases to the pericardium. The most common arelung (37% of malignant effusions), breast (22%), and leukemia/lymphoma(17%). Patients with HIV, with or without AIDS, are found to haveincreased prevalence, with 41-87% having asymptomatic effusion and 13%having moderate-to-severe effusion, Strimel W. J. et al, (2006).“Pericardial Effusion.” http://www.emedicine.com/med/topic1786.htm.

End-stage renal disease is a major public health problem. In the UnitedStates, more than 350,000 patients are being treated with eitherhemodialysis or continuous ambulatory peritoneal dialysis. Venkat A. etal. (2006). “Care of the end-stage renal disease patient on dialysis inthe ED.” Am J Emerg Med 24(7): 847-58. Renal failure is a common causeof pericardial disease, producing large pericardial effusions in up to20% of patients. Task Force members, Maisch B., Seferovic P, M., RisticA. D., Erbel R., Rienmuller R., Adler Y., Tomkowski W. Z., Thiene G.,Yacoub M. H., ESC Committee for Practice Guidelines, Priori S. G.,Alonso Garcia M. A., Blanc J.-J., Budaj A., Cowie M., Dean V., DeckersJ., Fernandez Burgos E., Lekakis J., Lindahl B., Mazzotta G., MoraiesJ., Oto A., Smiseth O. A., Document Reviewers, Acar J., Arbustini E.,Becker A. E., Chiaranda G., Hasin Y., Jenni R., Klein W., Lang I.,Luscher T. F., Pinto F. J., Shabetai R., Simoons M. L., Soler Soler J.,Spodick D. H. (2004). “Guidelines on the Diagnosis and Management ofPericardial Diseases Executive Summary: The Task Force on the Diagnosisand Management of Pericardial Diseases of the European Society ofCardiology.” Eur Heart J 25(7): 587-610.

Viral pericarditis is the most common infection of the pericardium.Inflammatory abnormalities are due to direct viral attack, the immuneresponse (antiviral or anticardiac), or both. Id. Purulent (bacterial)pericarditis in adults is rare, but always fatal if untreated. Mortalityrate in treated patients is 40%, mostly due to cardiac tamponade,toxicity, and constriction, It is usually a complication of an infectionoriginating elsewhere in the body, arising by contiguous spread orhaematogenous dissemination. Id. Other forms of pericarditis includetuberculous and neoplastic.

The most common secondary malignant tumors are lung cancer, breastcancer, malignant melanoma, lymphomas, and leukemias. Effusions may besmall or large with an imminent tamponade. In almost two-thirds of thepatients with documented malignancy pericardial effusion is caused bynon-malignant diseases, e.g., radiation pericarditis, or opportunisticinfections. The analyses of pericardial fluid, pericardial or epicardialbiopsy are essential for the confirmation of malignant pericardialdisease. Id.

Management of pericardial effusions continues to be a challenge. Thereis no uniform consensus regarding the best way to treat this difficultclinical entity. Approximately half the patients with pericardialeffusions present with symptoms of cardiac tamponade. In these cases,symptoms are relieved by pericardial decompression, irrespective of theunderlying cause. Georghiou G. P. et al, (2005). “Video-AssistedThoracoscopic Pericardial Window for Diagnosis and Management ofPericardial Effusions.” Ann Thorac Surg 80(2): 607-610. Symptomaticpericardiac effusions are common and may result from a variety ofcauses. When medical treatment has failed to control the effusion or adiagnosis is needed, surgical intervention is required. Id.

The most effective management of pericardial effusions has yet to beidentified. The conventional procedure is a surgically placedpericardial window under general anesthesia. This procedure portendssignificant operative and anesthetic risks because these patients oftenhave multiple comorbidities. Less invasive techniques such as blindneedle pericardiocentesis have high complication and recurrence rates.The technique of echocardiographic-guided pericardiocentesis withextended catheter drainage is performed under local anesthetic withintravenous sedation. Creating a pericardiostomy with a catheter inplace allows for extended drainage and sclerotherapy.Echocardiographic-guided pericardiocentesis has been shown to be a safeand successful procedure when performed at university-affiliated oracademic institutions. However, practices in community hospitals haverarely been studied in detail. Buchanan C. L. et al. (2003).“Pericardiocentesis with extended catheter drainage: an effectivetherapy.” Ann. Thorac. Surg. 76(3): 817-82.

The treatment of cardiac tamponade is drainage of the pericardialeffusion. Medical management is usually ineffective and should be usedonly while arrangements are made for pericardial drainage. Fluidresuscitation may be of transient benefit if the patient is volumedepleted (hypovolemic cardiac tamponade).

Surgical drainage (or pericardiectomy) is excessive for many patients.The best option is pericardiocentesis with the Seldinger technique,leaving a pigtail drainage catheter that should be kept in place untildrainage is complete. Sagrista Sauleda J. et al. (2005). “[Diagnosis andmanagement of acute pericardial syndromes],” Rev Esp Cardiol 58(7):830-41. This less-invasive technique resulted in a short operative timeand decreased supply, surgeon, and anesthetic costs. When comparingprocedure costs of a pericardial window versus an echo-guidedpericardiocentesis with catheter drainage at our institution, there wasa cost savings of approximately $1,800/case in favor of catheterdrainage. In an era of accelerating medical costs, these savings are ofconsiderable importance. Buchanan C. L. et al., 2003.

Currently, 0.2% of the U.S. population over 45 years of age (nearly200,000 patients) have reached a stage of severe congestive heartfailure (CHF) at which medical therapy is not sufficient to sustain anacceptable level of cardiac function. Since only approximately 2,000donor hearts are available in the U.S. each year for transplantation, itis necessary to have cardiac support or replacement. Baughman K. L, andJarcho J. A. (2007). “Bridge to Life—Cardiac Mechanical Support.” N.Engl. J. Med. 357(9): 846-849.

Although there has been important progress in pharmacological treatmentsfor CHF, such as Angiotensin-Converting Enzyme (ACE) inhibitors,beta-blockers, and aldosterone inhibitors that have significantlydecreased mortality, the progression from asymptomatic left ventriculardysfunction to symptomatic CHF is still a major issue. Mancini D. andBurkhoff D. (2005). “Mechanical Device-Based Methods of Managing andTreating Heart Failure.” Circulation 112(3): 438-448.

The purpose of many heart failure treatments is to slow, or reverse, theprocess. Several studies have demonstrated that a pharmacologicalblockade of the key neurohormonal pathways interrupts the vicious cycle,retards progression, and improves survival. Nevertheless, studiessuggest that attempts to block additional neurohormonal pathways may bedetrimental. These findings underscore the limit of pharmacologicaltreatments for heart failure. Id.

Regarding devices for treatment of CHF, there have been extensiveefforts to develop and test device-based therapies for patients withboth acute and chronic heart failure. For example, cardiacresynchronization therapy (CRT), myogenesis (e.g., stem cells andmyoblasts) and electrical therapies, such as less invasivedefibrillators, are under active investigation. Surgical reshaping ofthe dilated heart, including a reduction in the radius of curvature, candecrease wall stress, in principle allowing for reverse remodeling.Removal of dyskinetic scar is clinically accepted and reported to beassociated with satisfactory outcomes. The effects of removing akineticscar (often referred to as the Dor procedure or surgical anteriorventricular restoration (SAVR) are also under investigation. Anothermethod proposed to decrease wall stress and to induce reverse remodelingis by passive ventricular restraint devices. This concept evolved froman earlier investigational approach called cardiomyoplasty. Id.

In order to treat symptoms of heart failure due to mitral insufficiency,numerous catheter-based devices are being developed to perform mitralvalve repair percutaneously to reduce risk as a non-invasive procedure.Id.

For over 40 years, many researchers have pursued the development ofmechanical cardiac support. The earliest forms of clinical use wereintroduced in 1953 by the cardiopulmonary bypass, and was used forcardiopulmonary support during cardiac surgery. In 1962, theintra-aortic balloon counterpulsation was introduced and used fortemporary partial hemodynamic support improving myocardial contractilityand coronary perfusion. Neither approach provides full cardiacreplacement, however, even temporarily, as each approach is limited bythe invasive nature of the procedure, e.g. the requirement forlarge-bore cannulation of the femoral circulation limits the patient'smobility and restricts functional recovery. Risks of bleeding,thromboembolism, and infection also limit the feasible duration ofsupport. Baughman and Jarcho, 2007.

The intra-aortic balloon pump (IABP) is the most widely used of allcirculatory assist devices. Counterpulsation improves left ventricular(LV) performance by enhancing myocardial oxygen balance. It increasesmyocardial oxygen supply by diastolic augmentation of coronary perfusionand decreases myocardial oxygen requirements through a reduction in theafterload component of cardiac work. Azevedo C. F. et al. (2005). “Theeffect of intra-aortic balloon counterpulsation on left ventricularfunctional recovery early after acute myocardial infarction: arandomized experimental magnetic resonance imaging study.” Eur. Heart J,26(12): 1235-1241.

Support for the use of IABP in patients with acute myocardial infarction(AMI) has been based on the above theoretical consideration. However,the relationship between the beneficial physiological effect ofcounterpulsation and post-AMI LV functional recovery remains largelyundefined. In fact, several studies have investigated the immediateeffect of IABP on LV performance and demonstrated that, duringcounterpulsation, there is a significant improvement in LVhaemodynamics.

An important difference exists between the improved haemodynamicsprovided by counterpulsation itself and the possible favorable effect onpost-AMI non-assisted LV contractility. Id. Furthermore, it is importantto highlight that at twenty-four hours after reperfusion, the degree offunctional recovery was similar with or without IABP counterpulsation.Therefore, even though IABP counterpulsation may have an important rolein supporting and improving the clinical status of patients in the earlyphases of reperfused AMI, it does not seem to have a significantbeneficial effect in terms of long-term LV functional improvement. Id.

The available forms of mechanical cardiac support are devices known aspumps that can be classified into three types: centrifugal pumps,volume-displacement pumps, and axial-flow pumps. Moreover, threedistinct clinical indications for mechanical cardiac support have beendefined. Temporary support is instituted when recovery of native heartfunction is expected. Among patients who are candidates for hearttransplantation but who may not survive the waiting period for atransplant, a ventricular assist device may be used as a “bridge totransplantation.” Ultimately, for patients who are not candidates forheart transplant and for whom recovery of cardiac function is notprobable, a mechanical device may be utilized as “destination therapy”;i.e., as a permanent replacement for the native heart. This lastindication has only recently been established in clinical practice butis expected to be of growing importance in the future. Baughman andJarcho, 2007.

Despite the wide variety of pumps currently available, the problemsassociated with this technology have not changed since the early yearsof development. Id. Available devices for circulatory support usenumerous blood contacting pumps to assist the failing heart. Bloodremoved from the venous circulation is injected into the arterialcircuit in order to increase organ perfusion. Unfortunately, bloodcontact remains the core for major complications generally associatedwith mechanical circulatory support. Thromboembolic events, the need foranticoagulation, bleeding, hemolysis, immune suppression, and activationof the inflammatory system are factors which continue to threaten thoserequiring this therapy. Moreover, device implantation can be difficultand time-consuming which limits feasibility when cardiovascular collapseoccurs suddenly. These unsolved problems provide continued motivation todevelop non-blood contacting circulatory support devices. Instead ofunloading the heart, mechanical forces are directed toward increasingpump performance of the ventricular wall. Anstadt M. P. et al. (2002).“Non-blood contacting biventricular support for severe heart failure.”Ann. Thorac. Surg. 73(2): 556-562. These complex problems may becircumvented by a fundamentally different approach to cardiac assist.

Among all organs, the heart is unique in that oxygen extraction isnearly close to maximal. Thus, the only way that this metabolicallydemanding organ can increase oxygen consumption is by increasingcoronary blood flow. In this aspect of oxygen delivery, the heart isalso unique because most flow occurs in diastole instead of in systole.Carabello B. A. (2006). “Understanding Coronary Blood Flow: The Wave ofthe Future.” Circulation 113(14): 1721-1722.” The compression of thevasculature by the surrounding cardiac muscle during systole impedesflow so that while the pressure head for flow is maximum in systole,flow is maximum in diastole.

Waves are generated from both ends of the coronary vasculature, in thatproximal waves move forward and distal waves move backward. In thisscheme, proximal “pushing” waves and distal “suction” waves accelerateforward blood flow, while proximal suction waves and distal pushingwaves do the converse. Carabello, B. A., 2006. The forward-movingpushing wave is generated by systolic pressure. It drives bloodprimarily into the epicardial coronaries where it may be stored until itis released for forward flow when the myocardium relaxes. The secondimportant wave, typically the largest, is a suction wave generated byrelaxation of the left ventricle and is likely the main driver indiastolic coronary blood flow. Id.

Among patients with ischemic heart disease, it is of great importance toimprove the microvascular blood flow in the myocardium to protect themyocardium from infarction. Today, many different drugs andsophisticated techniques, such as percutaneous coronary intervention(PCI) and coronary artery bypass graft (CABG), are used with remarkableresults. Despite this, there is a large group of patients who have beenheavily treated with different drugs (leading to drug-resistant anginapectoris) who have already undergone one or more PCIs or CABG, or both,and who still have serious ischemic heart disease. A satisfactory modeof treatment for these patients has yet to be found. Lindstedt S. et al.(2007). “Blood Flow Changes in Normal and Ischemic Myocardium DuringTopically Applied Negative Pressure.” Ann. Thorac. Surg. 84(2): 568-573.

Despite the extensive clinical use and excellent outcome of topicalnegative pressure (TNP) in wound therapy, the fundamental scientificmechanism is, to a large extent, unknown. One of the known effects ofTNP is enhanced blood flow to the wound edge, as has been shown in asternotomy wound model. TNP increases blood flow velocity and opens upthe capillary beds. Mechanical forces exerted by TNP and increased bloodflow affect the cytoskeleton in the vascular cells and stimulategranulation tissue formation, which involves endothelial proliferation,capillary budding, and angiogenesis. Id.

As described herein, studies have shown that when myocardium was exposedto a topical negative pressure of −50 mm Hg, an immediate significantincrease in microvascular blood flow was observed. To investigatewhether similar results could be obtained in an ischemic model, the LADwas occluded for 20 minutes. When the ischemic area of the myocardiumwas exposed to a topical negative pressure of −50 mm Hg, an immediatesignificant increase in microvascular blood flow was detected.Furthermore, after 20 minutes of reperfusion, myocardial blood flowsignificantly increased when −50 mm Hg was applied. Lindstedt S. et al,(2007). Similar findings have been made with TNP of −25 mmHg.

TNP stimulation of myocardial blood flow may be a possible therapeuticintervention. It is believed that the sheering forces exerted by TNPstimulate angiogenesis. It has been observed in patients treated withTNP that richly vascularized granulation tissue develops over the heartwithin 4 to 5 days. These newly formed blood vessels may providecollateral blood supply that is needed when the native circulation failsto provide sufficient blood flow. It may be that the TNP stimulation ofblood flow and development of collateral blood vessels in part accountsfor the reduced long-term mortality in patients treated with TNP forpoststernotomy mediastinitis after CABG. Lindstedt S. et al, (2007).

The pericardium is a conical fibro-serous sac, in which the heart andthe roots of the great vessels are contained. The heart is placed behindthe sternum and the cartilages of the third to seventh ribs of the leftside, in the mediastinal cavity. Gray H. (1918). “Anatomy of the HumanBody.” Philadelphia: Lea & Febiger; Bartleby.com, 2000, pp. 1821-1865.The pericardium is separated from the anterior wall of the thorax, inthe greater part of its extent, by the lungs and pleurae. However, asmall area, somewhat variable in size and usually corresponding with theleft half of the lower portion of the body of the sternum and the medialends of the cartilages of the fourth and fifth ribs of the left side,comes into direct relationship with the chest wall. Behind, thepericardial sac rests upon the bronchi, the esophagus, the descendingthoracic aorta, and the posterior part of the mediastinal surface ofeach lung. Laterally, it is covered by the pleurae, and is in relationwith the mediastinal surfaces of the lungs. The phrenic nerve, with itsaccompanying vessels, descends between the pericardium and pleura oneither side. Id.

Similar to synovial joints in which moving surfaces may be separated bya thin fluid film at different stages of stance and walking, the heartand pericardium might be viewed as a load-bearing system in whichdeformable epicardial and pericardial sliding surfaces are separated bya lubricant. deVries G. et al. (2001). “A novel technique formeasurement of pericardial pressure,” Am. J. Physiol. Heart Circ.Physiol. 280(6): H2815-22.

The role played by the pericardium in cardiac hemodynamics is important.Almost a century ago. Barnard concluded that the pericardium can be asignificant constraint in filling of the heart. Barnard H. (1898). “Thefunctions of the pericardium.” J. Physiol. 22: 43-47. In a simpleexperiment, he isolated and inflated the pericardium of a dog with abicycle pump and observed that it did not rupture until pressures of 950to 1330 mm Hg. According to Barnard, “when a relaxed heart is subject toa venous pressure of from 10 to 20 mm Hg, the pericardium takes thestrain and prevents dilatation of the heart beyond a certain point. Thusthe mechanical disadvantages of dilated cavities and of a thinned wallare prevented.” Hamilton D. R. et al. (1994). “Right atrial and rightventricular transmural pressures in dogs and humans. Effects of thepericardium.” Circulation 90(5): 2492-500.

Gibbons Kroeker et al. showed that direct interaction between the leftventricle (LV) and right ventricle (RV) is mediated by the pericardium,as shown by a pericardium-mediated compensation for sudden changes inatrial volume. Gibbons Kroeker et al. (2006), “A 2D FE model of theheart demonstrates the role of the pericardium in ventriculardeformation.” Am. J. Physiol. Heart. Circ. Physiol. 291(5): H2229-36. Atlow strains, the pericardium is extremely distensible, but when strainsare greater than ten percent, the pericardium becomes very stiff.Consequently, over a range of lower heart volumes, the pericardium willexpand easily with the heart as it fills. At some point, however, itwill stiffen and become an ever tighter ring around the minor axis ofthe heart, resisting further expansion. Id.

Local contact forces between the pericardium and the heart causeregional variation in pericardial deformation during the cardiac cycle,reflecting volume changes of the underlying cardiac chambers. Goto Y.and LeWinter M. M. (1990). “Nonuniform regional deformation of thepericardium during the cardiac cycle in dogs.” Circ. Res. 67(5):1107-14. The measured left ventricular diastolic pressure is equal tothe sum of the pressure differences across the myocardium and thepericardium. Thus, increases in pericardial pressure raise measuredventricular diastolic pressure without change in ventricular volumewhich causes an upward shift in the pressure-volume curve. Tyberg J. V.et al, (1978). “A mechanism for shifts in the diastolic, leftventricular, pressure-volume curve: the role of the pericardium.” Eur.J. Cardiol. 7 Suppl: 163-75.

Noble gases, also known as the helium family or the neon family, are theelements in group 18 of the periodic table. Noble gases rarely reactwith other elements since they are already stable. Under normalconditions, they are odorless, colorless, monatomic gases, each havingits melting and boiling points close together so that only a smalltemperature range exists for each noble gas in which it is a liquid.Noble gases have numerous important applications in lighting, weldingand space technology. The seven noble gasses are: helium, neon, argon,krypton, xenon, radon, and ununoctium.

Helium (He) is a colorless, odorless, tasteless, non-toxic, inertmonatomic chemical element that heads the noble gas series in theperiodic table and whose atomic number is 2. The boiling and meltingpoints are the lowest among the elements and it exists only as a gasexcept in extreme conditions. Helium is less water soluble than anyother gas known, and it does not have any measurable viscosity becausethe speed of sound in helium is nearly three times the speed of sound inair.

Neutral helium at standard conditions is non-toxic, plays no biologicalrole, and is found in trace amounts in human blood. The addition ofhelium to a gas mixture prevents the occurrence of ventricularfibrillation. Helium has a definite protective effect againstventricular fibrillation when this preparation is used. The mechanism ofthe protective effect remains to be established. It is believed thathelium may increase collateral circulation in the ischemic area. PifarreR. et al. (1969). “Helium in the Prevention of VentricularFibrillation.” Chest 56(2): 135-138.

Clearly, there is a clinical need for a safe and effective approach totreat patients with congestive heart failure.

BRIEF SUMMARY

According to at least one embodiment of a device for assisting heartfunction of the present disclosure, the device comprises at least twoelectromagnetic plates, the at least two electromagnetic plates havingan inner surface, a cardiac processor electrically coupled to at leastone of the at least two electromagnetic plates, bladder having an innerchamber, the bladder attached to an inner surface of at least one of theat least two electromagnetic plates, a source of gas in communicationwith the inner chamber of the bladder, and at least one catheter havinga proximal end and a distal end and having a lumen therethrough, the atleast one catheter defining at least one aperture positionedtherethrough at or near the distal end of the at least one catheter andcomprising a pericardial balloon coupled to the at least one catheter ator near the distal end of the at least one catheter, the proximal end ofthe at least one catheter in communication with the inner chamber of thebladder, wherein when the distal end of the at least one catheter ispositioned within a pericardial space, the device operates to inject gasinto and/or remove gas from the pericardial balloon. In anotherembodiment, the at least two electromagnetic plates are operable tocompress the bladder, wherein the compression of the bladder injects gasinto the pericardial balloon to inflate the pericardial balloon. In yetanother embodiment, the at least two electromagnetic plates are operableto expand the bladder, wherein the expansion of the bladder removes gasfrom the pericardial balloon to deflate the pericardial balloon. In anadditional embodiment, gas enters the pericardial balloon from thebladder, through the lumen of the at least one catheter, and out fromthe at least one aperture defined within the at least one catheter. Inyet an additional embodiment, gas is removed from the pericardialballoon through the at least one aperture defined within the at leastone catheter, through the lumen of the at least one catheter, and intothe bladder.

According to at least one embodiment of a device for assisting heartfunction, when the distal end of the at least one catheter is positionedwithin the pericardial space at or near a heart chamber, inflation ofthe pericardial balloon exerts pressure on an epicardial wallsurrounding the heart chamber, and deflation of the pericardial balloonrelieves pressure on the epicardial wall, the inflation and deflation ofthe pericardial balloon operable to facilitate heart function. Inanother embodiment, the heart chamber is a left ventricle. In yetanother embodiment, the heart chamber is a right ventricle. In anadditional embodiment, the at least one catheter comprises a firstcatheter and a second catheter. In yet an additional embodiment, the atleast one catheter comprises three or more catheters.

According to at least one embodiment of a device for assisting heartfunction, when the distal end of the first catheter is positioned withinthe pericardial space at or near a first heart chamber, and wherein whenthe distal end of the second catheter is positioned within thepericardial space at or near a second heart chamber, inflation of thepericardial balloons coupled to the first catheter and the secondcatheter exerts pressure on an epicardial wall surrounding the firstheart chamber and the second heart chamber, and deflation of thepericardial balloons coupled to the first catheter and the secondcatheter relieves pressure on the epicardial wall, the inflation anddeflation of the pericardial balloons operable to facilitate heartfunction. In another embodiment, inflation and deflation of thepericardial balloon of the first catheter occurs during the times ofinflation and deflation, respectively, of the pericardial balloon of thesecond catheter. In yet another embodiment, the inflation and deflationof the pericardial balloons of the first and second catheters create acounterpulsation. In an additional embodiment, inflation and deflationof the pericardial balloon of the first catheter occurs at a differenttimes than the times of inflation and deflation, respectively, of thepericardial balloon of the second catheter. In yet an additionalembodiment, the first heart chamber is a left ventricle, and wherein thesecond heart chamber is a right ventricle.

According to at least one embodiment of a device for assisting heartfunction, the pericardial balloon is made of polyurethane. In anotherembodiment, the pericardial balloon has an inflation volume between 30and 40 cubic centimeters.

According to at least one embodiment of a method of assisting heartfunction, the method comprises the steps of providing a device forassisting heart function, comprising at least two electromagneticplates, the at least two electromagnetic plates having an inner surface,cardiac processor electrically coupled to at least one of the at leasttwo electromagnetic plates, a bladder having an inner chamber, thebladder attached to an inner surface of at least one of the at least twoelectromagnetic plates, a source of gas in communication with the innerchamber of the bladder, and at least one catheter having a proximal endand a distal end and having a lumen therethrough, the at least onecatheter defining at least one aperture positioned therethrough at ornear the distal end of the at least one catheter and comprising apericardial balloon coupled to the at least one catheter at or near thedistal end of the at least one catheter, the proximal end of the atleast one catheter in communication with the inner chamber of thebladder, and operating the device, when the distal end of the at leastone catheter is positioned within a pericardial space of a mammalianbody, to inject gas into and/or remove gas from the pericardial balloonto assist heart function.

In another embodiment, the at least two electromagnetic plates areoperable to compress the bladder, wherein the compression of the bladderinjects gas into the pericardial balloon to inflate the pericardialballoon. In yet another embodiment, the at least two electromagneticplates are operable to expand the bladder, wherein the expansion of thebladder removes gas from the pericardial balloon to deflate thepericardial balloon. In an additional embodiment, gas enters thepericardial balloon from the bladder, through the lumen of the at leastone catheter, and out from the at least one aperture defined within theat least one catheter.

According to at least one embodiment of a method of assisting heartfunction, gas is removed from the pericardial balloon through the atleast one aperture defined within the at least one catheter, through thelumen of the at least one catheter, and into the bladder. In anotherembodiment, when the distal end of the at least one catheter ispositioned within the pericardial space at or near a heart chamber,inflation of the pericardial balloon exerts pressure on an epicardialwall surrounding the heart chamber, and deflation of the pericardialballoon relieves pressure on the epicardial wall, the inflation anddeflation of the pericardial balloon operable to facilitate heartfunction. In yet another embodiment, the heart chamber is a leftventricle. In an additional embodiment, the heart chamber is a rightventricle. In yet an additional embodiment, the at least one cathetercomprises a first catheter and a second catheter. In another embodiment,the at least one catheter comprises three or more catheters.

In another embodiment, when the distal end of the first catheter ispositioned within the pericardial space at or near a first heartchamber, and wherein when the distal end of the second catheter ispositioned within the pericardial space at or near a second heartchamber, inflation of the pericardial balloons coupled to the firstcatheter and the second catheter exerts pressure on an epicardial wallsurrounding the first heart chamber and the second heart chamber, anddeflation of the pericardial balloons coupled to the first catheter andthe second catheter relieves pressure on the epicardial wall, theinflation and deflation of the pericardial balloons operable tofacilitate heart function. In yet another embodiment, inflation anddeflation of the pericardial balloon of the first catheter occurs duringthe times of inflation and deflation, respectively, of the pericardialballoon of the second catheter. In an additional embodiment, theinflation and deflation of the pericardial balloons of the first andsecond catheters create a counterpulsation. In yet an additionalembodiment, inflation and deflation of the pericardial balloon of thefirst catheter occurs at a different times than the times of inflationand deflation, respectively, of the pericardial balloon of the secondcatheter.

According to at least one embodiment of a method of assisting heartfunction, the first heart chamber is a left ventricle, and the secondheart chamber is a right ventricle.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows an embodiment of an engagement catheter and an embodimentof a delivery catheter as disclosed herein;

FIG. 1B shows a percutaneous intravascular pericardial delivery usinganother embodiment of an engagement catheter and another embodiment of adelivery catheter as disclosed herein;

FIG. 2A shows a percutaneous intravascular technique for accessing thepericardial space through a right atrial wall or atrial appendage usingthe engagement and delivery catheters shown in FIG. 1A;

FIG. 2B shows the embodiment of an engagement catheter shown in FIG. 2A;

FIG. 2C shows another view of the distal end of the engagement catheterembodiment shown in FIGS. 2A and 2B;

FIG. 3A shows removal of an embodiment of a catheter as disclosedherein;

FIG. 3B shows the resealing of a puncture according to an embodiment asdisclosed herein;

FIG. 4A to 4C show a closure of a hole in the atrial wall using anembodiment as disclosed herein;

FIG. 4D shows another closure of a hole in cardiac tissue using anotherembodiment as disclosed herein;

FIG. 4E shows yet another closure of a hole in cardiac tissue usinganother embodiment as disclosed herein;

FIG. 4F shows still another closure of a hole in cardiac tissue usinganother embodiment as disclosed herein;

FIG. 5A shows an embodiment of an engagement catheter as disclosedherein;

FIG. 5B shows a cross-sectional view of the proximal end of theengagement catheter shown in FIG. 5A;

FIG. 5C shows a cross-sectional view of the distal end of the engagementcatheter shown in FIG. 5A;

FIG. 5D shows the engagement catheter shown in FIG. 5A approaching aheart wall from inside of the heart;

FIG. 6A shows an embodiment of a delivery catheter as disclosed herein;

FIG. 6B shows a close-up view of the needle shown in FIG. 6A;

FIG. 6C shows a cross-sectional view of the needle shown in FIGS. 6A and6B;

FIG. 7 shows an embodiment of a delivery catheter as disclosed herein;

FIG. 8 shows an embodiment of a steering wire system within a steeringchannel;

FIG. 9A shows another embodiment of a steering wire system as disclosedherein, the embodiment being deflected in one location;

FIG. 9B shows the steering wire system shown in FIG. 9A, wherein thesteering wire system is deflected at two locations;

FIG. 9C shows the steering wire system shown in FIGS. 9A and 9B in itsoriginal position;

FIG. 10 shows a portion of another embodiment of a steering wire system;

FIG. 11 shows a cross-sectional view of another embodiment of a deliverycatheter as disclosed herein;

FIG. 12A shows an embodiment of a system for closing a hole in cardiactissue, as disclosed herein;

FIG. 12B shows another embodiment of a system for closing a hole incardiac tissue, as disclosed herein;

FIG. 12C shows another embodiment of a system for closing a hole incardiac tissue, as disclosed herein;

FIG. 13 shows another embodiment of a system for closing a hole incardiac tissue, as disclosed herein;

FIG. 14 shows another embodiment of a system for closing a hole incardiac tissue, as disclosed herein;

FIG. 15A shows another embodiment of a system for closing a hole incardiac tissue, as disclosed herein;

FIG. 15B shows the embodiment of FIG. 15A approaching cardiac tissue;

FIG. 15C shows the embodiment of FIGS. 15A-15C deployed on the cardiactissue;

FIG. 15D shows an embodiment of a system for closing an aperture incardiac tissue, as disclosed herein;

FIG. 15E shows an embodiment of a system for closing an aperture incardiac tissue wherein a coil has partially or fully closed the hole, asdisclosed herein;

FIG. 15F shows an embodiment of a coil of a system for closing anaperture in cardiac tissue, as disclosed herein;

FIG. 16A shows an embodiment of a portion of an apparatus for engaging atissue having a skirt positioned substantially within a sleeve, asdisclosed herein;

FIG. 16B shows another embodiment of a portion of an apparatus forengaging a tissue, as disclosed herein;

FIG. 16C shows an embodiment of a portion of an apparatus for engaging atissue having a skirt positioned substantially outside of a sleeve, asdisclosed herein;

FIG. 17A shows an embodiment of a portion of an apparatus for engaging atissue that has engaged a tissue, as disclosed herein;

FIG. 17B shows an embodiment of a portion of an apparatus for engaging atissue having an expanded skirt that has engaged a tissue, as disclosedherein;

FIG. 18A shows an embodiment of a portion of an apparatus for engaging atissue having a collapsed skirt present within a sleeve, as disclosedherein;

FIG. 18B shows an embodiment of a portion of an apparatus for engaging atissue having an expanded skirt, as disclosed herein;

FIG. 19 shows an embodiment of a system for engaging a tissue, asdisclosed herein;

FIG. 20A shows an embodiment of a portion of an apparatus for engaging atissue having a lead positioned therethrough, as disclosed herein;

FIG. 20B shows an embodiment of a portion of an apparatus for engaging atissue showing a needle, as disclosed herein;

FIG. 20C shows the embodiment of FIG. 20B having a lead positionedtherethrough.

FIG. 21A shows an embodiment of a portion of an apparatus for removingfluid from a tissue, as disclosed herein;

FIG. 21B shows an embodiment of a portion of an apparatus comprisinggrooves for removing fluid from a tissue, as disclosed herein;

FIG. 22 shows an embodiment of a portion of an apparatus for removingfluid from a tissue inserted within a heart, as disclosed herein;

FIG. 23A shows an embodiment of a catheter system with a deflatedballoon, as disclosed herein;

FIG. 23B shows an embodiment of a catheter system with an inflatedballoon, as disclosed herein;

FIG. 24 shows an embodiment of a catheter system positioned within thepericardial space surrounding a heart, as disclosed herein;

FIG. 25A shows an embodiment of a portion of a suction/infusioncatheter, apparatus as disclosed herein;

FIG. 25B shows an embodiment of a portion of a suction/infusion cathetercomprising grooves, as disclosed herein;

FIG. 26 shows an embodiment of a heart assist device with a deflatedbladder, as disclosed herein;

FIG. 27 shows an embodiment of a heart assist device with an inflatedbladder, as disclosed herein;

FIG. 28 shows a patient wearing an embodiment of a heart assist device,as disclosed herein;

FIG. 29A shows an embodiment of a suction/infusion catheter positionedwithin an inflated pericardial space, as disclosed herein;

FIG. 29B shows an embodiment of a suction/infusion catheter positionedwithin an inflated pericardial space, as disclosed herein;

FIG. 30A shows an embodiment of a suction/infusion catheter with apericardial balloon coupled thereto, as disclosed herein;

FIG. 30B shows the embodiment of FIG. 30A with an inflated pericardialballoon;

FIG. 31A shows an embodiment of a suction/infusion catheter positionedwithin a pericardial space surrounding a heart, as disclosed herein;

FIG. 31B shows the embodiment of FIG. 31A with an inflated pericardialballoon;

FIG. 32A shows an embodiment of a suction/infusion catheter with apericardial balloon positioned within a pericardial space at or near theleft ventricle of a heart, as disclosed herein; and

FIG. 32B shows an embodiment of a device/apparatus of the presentdisclosure comprising multiple suction/infusion catheters withpericardial balloons present within a pericardial space surrounding aheart, as disclosed herein.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of this disclosure is thereby intended.

The disclosed embodiments include devices, systems, and methods usefulfor accessing various tissues of the heart from inside the heart and isdirected to devices, systems, and methods for treating patients withcongestive heart failure (CHF), including those patients with adifferent functional class of CHF. For example, various embodimentsprovide for percutaneous, intravascular access into the pericardialspace through an atrial wall or the wall of an atrial appendage. In atleast some embodiments, the heart wall is aspirated and retracted fromthe pericardial sac to increase the pericardial space between the heartand the sac and thereby facilitate access into the space. Systems anddevices of the present disclosure are considered as a support for thenative heart contraction and as a non-blood contact system or device.Suction (to enhance myocardial perfusion in diastole) and compression(to assist and unload the heart in systole) in the pericardial space aresynchronized with the cardiac cycle in accordance with the devices,systems, and methods of the present disclosure.

The devices, systems, and methods of the present disclosure arecharacterized by the use of the pericardial sac (the space betweenparietal pericardium and visceral pericardium) as a pump bladder. Theinjection and suction of a noble gas through a catheter of the presentdisclosure in to and out of the heart is performed in a controlledmanner by synchrony with the cardiac cycle.

The present disclosure provides interesting new revelations on howtopically applied negative pressure may improve microvascular blood flowin the myocardium. Studies have shown that when myocardium was exposedto a topical negative pressure of −50 mm Hg, an immediate significantincrease in microvascular blood flow was observed. This is in accordancewith previous results showing increased microvascular blood flow of theskeletal muscle upon application of TNP. Lindstedt S. et al. (2007). Thedevices, systems, and methods of the present disclosure relate to suchan improvement in blood flow by novel and beneficial means as describedherein.

Unlike the relatively stiff pericardial sac, the atrial wall and atrialappendage are rather soft and deformable. Hence, suction of the atrialwall or atrial appendage can provide significantly more clearance of thecardiac structure from the pericardium as compared to suction of thepericardium. Furthermore, navigation from the intravascular region(inside of the heart) provides more certainty of position of vitalcardiac structures than does intrathoracic access (outside of theheart).

Access to the pericardial space may be used for identification ofdiagnostic markers in the pericardial fluid; for pericardiocentesis; andfor administration of therapeutic factors with angiogenic, myogenic, andantiarrhythmic potential. In addition, as explained in more detailbelow, epicardial pacing leads may be delivered via the pericardialspace, and an ablation catheter may be used on the epicardial tissuefrom the pericardial space.

In the embodiment of the catheter system shown in FIG. 1A, cathetersystem 10 includes an engagement catheter 20, a delivery catheter 30,and a needle 40. Although each of engagement catheter 20, deliverycatheter 30, and needle 40 has a proximal end and a distal end. FIG. 1Ashows only the distal end. Engagement catheter 20 has a lumen throughwhich delivery catheter 30 has been inserted, and delivery catheter 30has a lumen through which needle 40 has been inserted. Delivery catheter30 also has a number of openings 50 that can be used to transmit fluidfrom the lumen of the catheter to the heart tissue in close proximity tothe distal end of the catheter.

As shown in more detail in FIGS. 2A, 2B, 2C, engagement catheter 20includes a vacuum channel 60 used for suction of a targeted tissue 65 inthe heart and an injection channel 70 used for infusion of substances totargeted tissue 65, including, for example, a biological ornon-biological degradable adhesive. As is shown in FIGS. 2B and 2C,injection channel 70 is ring-shaped, which tends to provide relativelyeven dispersal of the infused substance over the targeted tissue, butother shapes of injection channels may be suitable. A syringe 80 isattached to injection channel 70 for delivery of the appropriatesubstances to injection channel 70, and a syringe 90 is attached tovacuum channel 60 through a vacuum port (not shown) at the proximal endof engagement catheter 20 to provide appropriate suction through vacuumchannel 60. At the distal end of engagement catheter 20, a suction port95 is attached to vacuum channel 60 for contacting targeted tissue 65,such that suction port 95 surrounds targeted tissue 65, which is therebyencompassed within the circumference of suction port 95. Althoughsyringe 90 is shown in FIG. 2B as the vacuum source providing suctionfor engagement catheter 20, other types of vacuum sources may be used,such as a controlled vacuum system providing specific suction pressures.Similarly, syringe 80 serves as the external fluid source in theembodiment shown in FIG. 2B, but other external fluid sources may beused.

A route of entry for use of various embodiments disclosed herein isthrough the jugular or femoral vein to the superior or inferior venacavae, respectively, to the right atrial wall or atrial appendage(percutaneously) to the pericardial sac (through puncture).

Referring now to FIG. 1B, an engagement catheter 100 is placed viastandard approach into the jugular or femoral vein. The catheter, whichmay be 4 or 5 Fr., is positioned under fluoroscopic or echocardiographicguidance into the right atrial appendage 110. Suction is initiated toaspirate a portion of atrial appendage 110 away from the pericardial sac120 that surrounds the heart. As explained herein, aspiration of theheart tissue is evidenced when no blood can be pulled back throughengagement catheter 100 and, if suction pressure is being measured, whenthe suction pressure gradually increases. A delivery catheter 130 isthen inserted through a lumen of engagement catheter 100. A smallperforation can be made in the aspirated atrial appendage 110 with aneedle such as needle 40, as shown in FIGS. 1A and 2A. A guide wire (notshown) can then be advanced through delivery catheter 130 into thepericardial space to secure the point of entry 125 through the atrialappendage and guide further insertion of delivery catheter 130 oranother catheter. Flouroscopy or echocardiogram can be used to confirmthe position of the catheter in the pericardial space. Alternatively, apressure tip needle can sense the pressure and measure the pressurechange from the atrium (about 10 mmHg) to the pericardial space (about 2mmHg). This is particularly helpful for transeptal access where punctureof arterial structures (e.g., the aorta) can be diagnosed and sealedwith an adhesive, as described in more detail below.

Although aspiration of the atrial wall or the atrial appendage retractsthe wall or appendage from the pericardial sac to create additionalpericardial space, CO2 gas can be delivered through a catheter, such asdelivery catheter 130, into the pericardial space to create additionalspace between the pericardial sac and the heart surface.

Referring now to FIG. 3A, the catheter system shown in FIG. 1B isretrieved by pull back through the route of entry. However, the punctureof the targeted tissue in the heart (e.g., the right atrial appendage asshown in FIG. 3A) may be sealed upon withdrawal of the catheter, whichprevents bleeding into the pericardial space. The retrieval of thecatheter may be combined with a sealing of the tissue in one of severalways: (1) release of a tissue adhesive or polymer 75 via injectionchannel 70 to seal off the puncture hole, as shown in FIG. 3B; (2)release of an inner clip or mechanical stitch to close off the hole fromthe inside of the cavity or the heart, as discussed herein; or (3)mechanical closure of the heart with a sandwich type mechanical devicethat approaches the hole from both sides of the wall (see FIGS. 4A, 4B,and 4C). In other words, closure may be accomplished by using, forexample, a biodegradable adhesive material (e.g., fibrin glue orcyanomethacrylate), a magnetic system, or an umbrella-shaped nitinolstent. An example of the closure of a hole in the atrium is shown inFIG. 3B. Engagement catheter 20 is attached to targeted tissue 95 usingsuction through suction port 60. Tissue adhesive 75 is injected throughinjection channel 70 to coat and seal the puncture wound in targetedtissue 95. Engagement catheter 20 is then withdrawn, leaving a plug oftissue adhesive 75 attached to the atrial wall or atrial appendage.

Other examples for sealing the puncture wound in the atrial wall orappendage are shown in FIGS. 4A-4F. Referring now to FIGS. 4A-4C, asandwich-type closure member, having an external cover 610 and aninternal cover 620, is inserted through the lumen of engagement catheter600, which is attached to the targeted tissue of an atrial wall 630.Each of external and internal covers 610 and 620 is similar to anumbrella in that it can be inserted through a catheter in its foldedconfiguration and expanded to an expanded configuration once it isoutside of the catheter. As shown in FIG. 4A, external cover 610 isdeployed (in its expanded configuration) on the outside of the atrialwall to seal a puncture wound in the targeted tissue, having alreadybeen delivered through the puncture wound into the pericardial space.Internal cover 620 is delivered through engagement catheter 600 (in itsfolded configuration), as shown in FIGS. 4A and 4B, by an elongateddelivery wire 615, to which internal cover 620 is reversibly attached(for example, by a screw-like mechanism). Once internal cover 620 is inposition on the inside of atrial wall 630 at the targeted tissue,internal cover 620 is deployed to help seal the puncture wound in thetargeted tissue (see FIG. 4C).

Internal cover 620 and external cover 610 may be made from a number ofmaterials, including a shape-memory alloy such as nitinol. Suchembodiments are capable of existing in a catheter in a foldedconfiguration and then expanding to an expanded configuration whendeployed into the body. Such a change in configuration can result from achange in temperature, for example. Other embodiments of internal andexternal covers may be made from other biocompatible materials anddeployed mechanically.

After internal cover 620 is deployed, engagement catheter 600 releasesits grip on the targeted tissue and is withdrawn, leaving thesandwich-type closure to seal the puncture wound, as shown in FIG. 4C.External cover 610 and internal cover 620 may be held in place using abiocompatible adhesive. Similarly, external cover 610 and internal cover620 may be held in place using magnetic forces, such as, for example, bythe inside face (not shown) of external cover 610 comprising a magnet,by the inside face (not shown) of internal cover 620 comprising amagnet, or both inside faces of external cover 610 or internal cover 620comprising magnets.

In the embodiment shown in FIGS. 4A, 4B, and 4C, the closure membercomprises external cover 610 and internal cover 620. However, in atleast certain other embodiments, the closure member need not have twocovers. For example, as shown in FIG. 4D, closure member 632 is made ofonly one cover 634. Cover 634 has a first face 636 and a second face638, and first face 636 is configured for reversible attachment todistal end 642 of delivery wire 640. Closure member 632 may be made ofany suitable material, including nitinol, which is capable oftransitioning from a folded configuration to an expanded configuration.

In the embodiment shown in FIG. 4E, a closure member 1500 comprises anexternal cover 1510 and an internal cover 1520 within a deliverycatheter 1530. External cover 1510 and internal cover 1520 are attachedat a joint 1540, which may be formed, for example, by a mechanicalattachment or by a magnetic attachment. In embodiments having a magneticattachment, each of the external cover and the internal cover may have aferromagnetic component that is capable of magnetically engaging theother ferromagnetic component.

Delivery catheter 1530 is shown after insertion through hole 1555 ofatrial wall 1550. Closure member 1500 may be advanced through deliverycatheter 1530 to approach atrial wall 1550 by pushing rod 1560. Rod 1560may be reversibly attached to internal cover 1520 so that rod 1560 maybe disconnected from internal cover 1520 after closure member 1500 isproperly deployed. For example, rod 1560 may engage internal cover 1520with a screw-like tip such that rod 1560 may be easily unscrewed fromclosure member 1500 after deployment is complete. Alternatively, rod1560 may simply engage internal cover 1520 such that internal cover 1520may be pushed along the inside of delivery catheter 1530 withoutattachment between internal cover 1520 and rod 1560.

Closure member 1500 is advanced through delivery catheter 1530 untilexternal cover 1510 reaches a portion of delivery catheter 1530 adjacentto atrial wall 1550; external cover 1510 is then pushed slowly out ofdelivery catheter 1530 into the pericardial space. External cover 1510then expands and is positioned on the outer surface of atrial wall 1550.When external cover 1510 is properly positioned on atrial wall 1550,joint 1540 is approximately even with atrial wall 1550 within hole 1555.Delivery catheter 1530 is then withdrawn slowly, causing hole 1555 toclose slightly around joint 1540. As delivery catheter 1530 continues tobe withdrawn, internal cover 1520 deploys from delivery catheter 1530,thereby opening into its expanded formation. Consequently, atrial wall1550 is pinched between internal cover 1520 and external cover 1510, andhole 1555 is closed to prevent leakage of blood from the heart.

FIG. 4F shows the occlusion of a hole (not shown) in atrial wall 1600due to the sandwiching of atrial wall 1600 between an external cover1610 and an internal cover 1620. External cover 1610 is shown deployedon the outside surface of atrial wall 1600, while internal cover 1620 isdeployed on the inside surface of atrial wall 1600. As shown, rod 1640is engaged with internal cover 1620, and delivery catheter 1630 is inthe process of being withdrawn, which allows internal cover 1620 tofully deploy. Rod 1640 is then withdrawn through delivery catheter 1630.An engagement catheter (not shown) may surround delivery catheter 1650,as explained more fully herein.

Other examples for sealing a puncture wound in the cardiac tissue areshown in FIGS. 12-15. Referring now to FIG. 12A, there is shown a plug650 having a first end 652, a second end 654, and a hole 656 extendingfrom first end 652 to second end 654. Plug 650 may be made from anysuitable material, including casein, polyurethane, silicone, andpolytetrafluoroethylene. Wire 660 has been slidably inserted into hole656 of plug 650. Wire 660 may be, for example, a guide wire or a pacinglead, so long as it extends through the hole in the cardiac tissue (notshown). As shown in FIG. 12A, first end 652 is covered with a radiopaquematerial, such as barium sulfate, and is therefore radiopaque. Thisenables the clinician to view the placement of the plug in the bodyusing radiographic imaging. For example, the clinician can confirm thelocation of the plug during the procedure, enabling a safer and moreeffective procedure for the patient.

As shown in FIG. 12A, first end 652 of plug 650 has a smaller diameterthan second end 654 of plug 650. Indeed, plug 680 shown FIG. 12B andplug 684 shown in FIGS. 13 and 14 have first ends that are smaller indiameter than their respective second ends. However, not all embodimentsof plug have a first end that is smaller in diameter than the secondend. For example, plug 682 shown in FIG. 12C has a first end with adiameter that is not smaller than the diameter of the second end. Bothtypes of plug can be used to close holes in cardiac tissue.

Referring again to FIG. 12A, elongated shaft 670 has a proximal end (notshown), a distal end 672, and a lumen 674 extending from the proximalend to distal end 672. Although no catheter is shown in FIG. 12A, plug650, wire 660, and shaft 670 are configured for insertion into a lumenof a catheter (see FIG. 14), such as an embodiment of an engagementcatheter disclosed herein. Plug 650 and shaft 670 are also configured tobe inserted over wire 660 and can slide along wire 660 because each oflumen 656 of plug 650 and lumen 674 of shaft 670 is slightly larger incircumference than wire 660.

As shown in FIGS. 13 and 14, shaft 672 is used to push plug 684 alongwire 674 within elongated tube 676 to and into the hole in the targetedcardiac tissue 678. Distal end 677 of elongated tube 676 is shownattached to cardiac tissue 678, but distal end 677 need not be attachedto cardiac tissue 678 so long as distal end 677 is adjacent to cardiactissue 678. Once plug 684 is inserted into the hole, wire 674 may bewithdrawn from the hole in plug 684 and the interior of the heart (notshown) and shaft 672 is withdrawn from elongated tube 676. In someembodiments, the plug is self-sealing, meaning that the hole of the plugcloses after the wire is withdrawn. For example, the plug may be madefrom a dehydrated protein matrix, such as casein or ameroid, whichswells after soaking up fluid. After shaft 672 is withdrawn, elongatedtube 676 can be withdrawn from the heart.

It should be noted that, in some embodiments, the wire is not withdrawnfrom the hole of the plug. For example, where the wire is a pacing lead,the wire may be left within the plug so that it operatively connects tothe CRT device.

Referring now to FIG. 12B, there is shown a plug 680 that is similar toplug 684. However, plug 680 comprises external surface 681 having aridge 683 that surrounds plug 680 in a helical or screw-like shape.Ridge 683 helps to anchor plug 680 into the hole of the targeted tissue(not shown). Other embodiments of plug may include an external surfacehaving a multiplicity of ridges surrounding the plug, for example, in acircular fashion.

FIGS. 15A-15C show yet another embodiment of a closure member forclosing a hole in a tissue. Spider clip 1700 is shown within catheter1702 and comprises a head 1705 and a plurality of arms 1710, 1720, 1730,and 1740. Each of arms 1710, 1720, 1730, and 1740 is attached at itsproximal end to head 1705. Although spider clip 1700 has four arms,other embodiments of spider clip include fewer than, or more than, fourarms. For example, some embodiments of spider clip have three arms,while others have five or more arms.

Referring again to FIGS. 15A-15C, arms 1710, 1720, 1730, and 1740 may bemade from any flexible biocompatible metal that can transition betweentwo shapes, such as a shape-memory alloy (e.g., nitinol) or stainlesssteel. Spider clip 1700 is capable of transitioning between an openposition (see FIG. 15A), in which the distal ends of its arms 1710,1720, 1730, and 1740 are spaced apart, and a closed position (see FIG.15C), in which the distal ends of arms 1710, 1720, 1730, and 1740 aregathered together. For embodiments made from a shape-memory alloy, theclip can be configured to transition from the open position to theclosed position when the metal is warmed to approximately bodytemperature, such as when the clip is placed into the cardiac tissue.For embodiments made from other types of metal, such as stainless steel,the clip is configured in its closed position, but may be transitionedinto an open position when pressure is exerted on the head of the clip.Such pressure causes the arms to bulge outward, thereby causing thedistal ends of the arms to separate.

In this way, spider clip 1700 may be used to seal a wound or hole in atissue, such as a hole through the atrial wall. For example, FIG. 15Bshows spider clip 1700 engaged by rod 1750 within engagement catheter1760. As shown, engagement catheter 1760 has a bell-shaped suction port1765, which, as disclosed herein, has aspirated cardiac tissue 1770.Cardiac tissue 1770 includes a hole 1775 therethrough, and suction port1765 fits over hole 1775 so as to expose hole 1775 to spider clip 1700.

Rod 1750 pushes spider clip 1700 through engagement catheter 1760 toadvance spider clip 1700 toward cardiac tissue 1770. Rod 1750 simplyengages head 1705 by pushing against it, but in other embodiments, therod may be reversibly attached to the head using a screw-type system. Insuch embodiments, the rod may be attached and detached from the headsimply by screwing the rod into, or unscrewing the rod out of, the head,respectively.

In at least some embodiments, the spider clip is held in its openposition during advancement through the engagement catheter by thepressure exerted on the head of the clip by the rod. This pressure maybe opposed by the biasing of the legs against the engagement catheterduring advancement.

Referring to FIG. 15C, spider clip 1700 approaches cardiac tissue 1770and eventually engages cardiac tissue 1770 such that the distal end ofeach of arms 1710, 1720, 1730, and 1740 contacts cardiac tissue 1770.Rod 1750 is disengaged from spider clip 1700, and spider clip 1700transitions to its closed position, thereby drawing the distal ends ofarms 1710, 1720, 1730, and 1740 together. As the distal ends of the armsare drawn together, the distal ends grip portions of cardiac tissue1770, thereby collapsing the tissue between arms 1710, 1720, 1730, and1740 such that hole 1775 is effectively closed.

Rod 1750 is then withdrawn, and engagement catheter 1760 is disengagedfrom cardiac tissue 1770. The constriction of cardiac tissue 1770 holdshole 1775 closed so that blood does not leak through hole 1775 afterengagement catheter 1760 is removed. After a relatively short time, thebody's natural healing processes permanently close hole 1775. Spiderclip 1700 may remain in the body indefinitely.

FIG. 15D shows an exemplary embodiment of a system for closing anaperture in a tissue according to the present disclosure. As shown inFIG. 15D, system 3800 comprises a catheter 3802, including, but nolimited to, an engagement, delivery, and/or suction/infusion catheter asdescribed herein, and further comprises a coil 3804 and a shaft 3806positioned within an internal lumen of catheter 3802. In the exemplaryembodiment shown in FIG. 15D, an optional guide wire 3808 may be used tofacilitate the positioning of catheter 3802 to an atrial wall 3810. Inat least one embodiment, catheter 3802 comprises an engagement catheter,wherein the engagement catheter has engaged an atrial wall 3810, andwherein an aperture within atrial wall 3810 allows, for example, a guidewire 3808, a delivery catheter, a suction/infusion catheter, and/oranother device or apparatus to enter the aperture within the atrial wall3810.

In at least one embodiment, coil 3804 is substantially straight when itis introduced within a lumen of a catheter 3802. In another embodiment,coil 3804 is somewhat, but not fully, coiled as it is introduced withinthe lumen of catheter 3800. In at least one embodiment, coil 3804comprises a “memory,” wherein the memory comprises a firstconfiguration. In an exemplary embodiment, the first configuration is anuncompressed configuration. In another embodiment, the memory furthercomprises a second configuration, and in at least one embodiment, thesecond configuration is a compressed configuration. In at least oneembodiment, coil 3804 is fluoroscopic so that a user of coil 3804 mayuse, for example, x-ray technology, to assist with placement of coil3804 within a body.

In the exemplary embodiment shown in FIG. 15D, coil 3804 is positionedwithin the lumen of catheter 3802, and as coil 3804 is introduced at ornear the atrial wall 3810, a portion of coil 3804 is positioned withinan aperture within atrial wall 3810. When positioned, coil 3804 may becompressed using, for example, shaft 3806, whereby shaft 3806 exertspressure upon coil 3804, causing coil 3804 to compress at or near theaperture within atrial wall 3810. In the embodiment shown in FIG. 15E,shaft 3806 has exerted pressure upon coil 3804, causing coil 3804 tocompress on both sides of atrial wall 3810 (with part of coil 3804positioned within a pericardial sac and part of the coil positionedwithin an atrial cavity). This compression may then facilitate closureof an aperture within atrial wall 3810, as portions of coil 3804, whencompressed as shown in FIG. 15E, may exert pressure on one or both sidesof atrial wall 3810, wherein the aperture within atrial wall 3810 mayeither be partially or fully occluded by coil 3804. FIG. 15F shows anexemplary embodiment of a coil 3804 in a compressed formation.

It can be appreciated that pressure exerted upon coil 3804 by shaft 3806may also facilitate placement of coil 3804 at or near an aperture withinatrial wall 3810. In at least one embodiment, coil 3804 may be “screwed”into an aperture within atrial wall 3810, using shaft 3806 and/or byphysically turning coil 3804 as it is positioned within atrial wall3810. In addition, and in at least one embodiment, guide wire 3808 mayfacilitate placement of coil 3804 within an aperture of atrial wall3810.

Any number of materials may be used to form coil 3804, including, butnot limited to, nitinol and/or stainless steel. In addition, coil 3804may be coated with one or more materials, including, but not limited to,polytetrafluoroethylene (PTFE), polyethylene terephthalate (Dacron, forexample), and/or polyurethane. In addition, one or more other materials,including, but not limited to, materials known in the art to facilitateblood coagulation, including, but not limited to, cotton fibers, may becoupled to coil 3804 to facilitate aperture occlusion.

FIGS. 16A, 16B, and 16C show an embodiment of a portion of an apparatusfor engaging a tissue as disclosed herein. As shown in FIG. 16A, asleeve 1800 is present around at least a portion of an engagementcatheter 1810. Sleeve 1800, as described herein, may comprise a rigid orflexible tube having a lumen therethrough, appearing around the outsideof engagement catheter 1810 and slidingly engaging engagement catheter1810. In at least the embodiment shown in FIG. 16A, the distal end 1820of engagement catheter 1810 comprises a skirt 1830, shown in FIG. 16A asbeing housed within sleeve 1800. A delivery catheter 1840 may be presentwithin engagement catheter 1810 as shown to facilitate the delivery of aproduct (gas, liquid, and/or particulate(s)) to a target site. In thisembodiment, delivery catheter 1840 is present at least partially withinthe lumen of engagement catheter 1810, and engagement catheter is placedat least partially within the lumen of sleeve 1800.

Referring now to FIG. 16B, an embodiment of an apparatus as shown inFIG. 16A or similar to the embodiment shown in FIG. 16A is shown withsleeve 1800 being “pulled back” from the distal end of engagementcatheter 1810. As shown in FIG. 16B, as sleeve 1800 is pulled back (inthe direction of the arrow), skirt 1830 becomes exposed, and as sleeve1800 is no longer present around skirt 1830, skirt 1830 may optionallyexpand into a frusto-conical (“bell-shaped”) skirt 1830. Skirt 1830 maybe reversibly deformed (collapsed) when present within the lumen ofsleeve 1800 as shown in FIG. 16A and in FIG. 18A described in furtherdetail herein. It can be appreciated that many alternativeconfigurations of skirt 1830 to the frusto-conical configuration mayexist, including an irregular frusto-conical configuration, noting thata configuration of skirt 1830 having a distal portion (closest to atissue to be engaged) larger than a proximal position may benefit fromsuction of a larger surface area of a tissue as described in furtherdetail herein.

FIG. 16C shows an embodiment of an apparatus described herein having anexpanded skirt 1830. As shown in FIG. 16C, sleeve 1800 has been pulledback (in the direction of the arrow) so that the expanded configurationof skirt 1830 may be present to engage a tissue (not shown).

FIGS. 17A and 17B shown alternative embodiments of a portion of anapparatus for engaging a tissue as described herein. FIGS. 17A and 17Beach show a sleeve 1800, an engagement catheter 1810 having a skirt1830, and a delivery catheter 1840. In each figure, skirt 1830 is shownengaging a surface of a tissue 1850. In the embodiments shown in FIGS.17A and 17B, the relative sizes of the sleeves 1800, engagementcatheters 1810, and delivery catheters 1840 are similar as shown, butthe relative sizes of the skirts 1830 of the engagement catheters 1810are clearly different. The exemplary embodiment of the portion of anapparatus for engaging a tissue shown in FIG. 17A comprises a skirt 1830of the same or substantially similar relative size as the engagementcatheter 1810, meaning that the diameters of the engagement catheter1810 and the skirt 1830 shown in FIG. 17A are approximately the same.Conversely, the exemplary embodiment of the portion of an apparatus forengaging a tissue shown in FIG. 17B comprises a skirt 1830 notablylarger than the engagement catheter 1810, meaning that the diameters ofthe engagement catheter 1810 and the skirt 1830 at its widest pointshown in FIG. 17B are notably different. As shown in FIG. 17B, as skirt1830 extends from engagement catheter 1810 to tissue 1850, the diameterof skirt 1830 increases. As such, skirt 1830 of the embodiment shown inFIG. 17B may engage a larger surface area of a tissue (shown by 1860)than the embodiment of the skirt 1830 shown in FIG. 17A. The ability toengage a larger surface area of a tissue 1850 by skirt 1830 allows abetter reversible engagement of a tissue 1850 when a vacuum is providedas described in detail herein. This improved suction allows a personusing such an apparatus to more effectively engage a tissue 1850 thanwould otherwise be possible when skirt 1830 engages a smaller surfacearea of a tissue.

FIGS. 18A and 18B show perspective views of an embodiment of a portionof an apparatus for engaging a tissue. FIG. 18A represents an embodimentwhereby a skirt 1830 of an engagement catheter 1810 is positionedsubstantially within a sleeve 1800. FIG. 18B represents an embodimentwhereby a skirt 1830 of an engagement catheter 1810 is positionedoutside of s 1800. As such, the positioning of skirt 1830 within sleeve1800 can be seen in the embodiments of FIGS. 16A and 18A, and thepositioning of skirt 1830 outside of sleeve 1800 can be seen in theembodiments of FIGS. 16C and 18B.

As shown in FIG. 18A, skirt 1830 of engagement catheter 1810 ispositioned within sleeve 1800, whereby the configuration of skirt 1830is collapsed so that skirt 1830 may fit within sleeve 1800. As sleeve1800 moves in the direction of the arrow shown in FIG. 18B, skirt 1830becomes exposed and its configuration is allowed to expand because thereare no constraints provided by the inner wall of sleeve 1800.

The embodiments shown in FIGS. 18A and 18B also show an exemplaryembodiment of a configuration of an engagement catheter 1810. As shownin FIG. 18B, engagement catheter 1810 defines a number of apertures(representing lumens) present at the distal end of engagement catheter1810 (at the proximal end of skirt 1830), including, but not limited to,one or more vacuum ports 1870 (representing the aperture at or near thedistal end of a vacuum tube), and a delivery port 1880 (representing theaperture at or near the distal end of a delivery tube). A vacuum source(not shown) may be coupled to a suction port located at a proximal endof one or more vacuum tubes as described herein, whereby gas, fluid,and/or particulate(s) may be introduced into one or more vacuum ports1870 by the introduction of a vacuum at a vacuum port. Gas, fluid,and/or particulate(s) may be introduced from delivery aperture 1880 to atissue (not shown in FIG. 18A or 18B).

As shown by the exemplary embodiments of FIGS. 17A and 17B, the abilityfor a user of such an apparatus for engaging a tissue to obtain propersuction depends at least in part on the relative placement of skirt 1830and delivery catheter 1840 at or near a tissue 1850. As described indetail herein regarding the exemplary embodiment shown in FIG. 5D, if avacuum source provides suction through one or more vacuum ports 1870(shown in FIGS. 18A and 18B), but skirt 1830 has not effectively engageda tissue 1850, gas, fluid, and/or particulate(s) in the area of tissue1850 and/or gas, fluid and/or particulate(s) delivered via deliverycatheter 1840 to the area of tissue 1850 may be aspirated by one or morevacuum ports 1870. In a situation where skirt 1830 has effectivelyengaged a tissue 1850 but where delivery catheter 1840 has not engaged atissue 1850, any gas, liquid, and/or particulate(s) delivered bydelivery catheter 1840 may be aspirated by one or more vacuum ports1870. In a situation where skirt 1830 and delivery catheter 1840 haveeffectively engaged a tissue 1850, most, if not all, of any gas, liquid,and/or particulate(s) delivered by delivery catheter 1840 to tissue 1850would not be aspirated by one or more vacuum ports 1870 as the placementof delivery catheter 1840 on or within tissue 1850 would provide directdelivery at or within tissue 1850.

An exemplary embodiment of a system and/or device for engaging a tissueas described herein is shown in FIG. 19. As shown in FIG. 19, anexemplary apparatus shows a sleeve 1800 which has been moved in thedirection of the arrow to reveal skirt 1830 at the distal end ofengagement catheter 1810, allowing skirt to resume an expanded,frusto-conical configuration. As shown in this embodiment, deliverycatheter 1840 has been introduced at the proximal end of the apparatus(in the direction shown by the dashed arrow), allowing delivery catheter1840 to exit out of a delivery lumen (not shown) at the distal end ofengagement catheter 1840. A needle 1890 may be present at the distal endof delivery catheter 1840, facilitating the potential puncture of atissue (not shown) to allow the distal end of delivery catheter 1840 toenter a tissue.

In addition, and as shown in the exemplary embodiment of FIG. 19, a lead1900 may be introduced into delivery catheter 1840 (in the directionshown by the dashed arrow), whereby the distal end of lead 1900 may exitan aperture of needle 1890 and optionally enter a tissue and/or a lumenof a tissue. As described herein, any number of suitable types of leads1900 may be used with the delivery catheters described herein, includingsensing leads and/or pacing leads. A vacuum source 1910 may also providea source of vacuum to such an apparatus to allow skirt 1830 to engage atissue using suction.

The exemplary embodiment of an apparatus for engaging a tissue as shownin FIG. 19 comprises an engagement catheter 1810 having a curvature.Such a curved engagement catheter 1810 allows a user of such anapparatus, for example, to insert a portion of the apparatus into a bodyor tissue from one direction, and engage a tissue with skirt 1830,delivery catheter 1840, needle 1890, and/or lead 1900 from anotherdirection. For example, a user may introduce a portion of an apparatusfrom one side of the heart, and the apparatus may engage the heart froma different direction than the direction of introduction of theapparatus.

It can also be appreciated that an exemplary embodiment of an apparatusof the present disclosure may be used to engage an internal portion ofan organ. As previously referenced herein, such an apparatus may be usedto engage the surface of a tissue. However, it can be appreciated thatsuch a tissue may be an outer surface of any number of tissues,including, but not limited to, a heart, lungs, intestine, stomach, orany number of other organs or tissues. It can also be appreciated thatsome of these types of organs or tissues, including the heart forexample, may have one or more internal tissue surfaces capable of beingengaged by an apparatus of the present disclosure. For example, a userof such an apparatus may use the apparatus to engage the septum of theheart dividing one side of the heart from another. Such use mayfacilitate the delivery of a gas, liquid, and/or particulate(s) to aparticular side of the heart, as such a targeted delivery may providebeneficial effects, including, but not limited to, the ability todeliver a lead to pace the inner wall of the left side of the heart.

Referring now to FIGS. 20A, 20B, and 20C, embodiments of a portion of anapparatus for engaging a tissue according to the present disclosure areshown. As shown in FIG. 20A, an exemplary embodiment of a portion of anapparatus for engaging a tissue comprises sleeve 1800 slidingly engagingengagement catheter 1810, and when sleeve 1800 is slid in the directionof the arrow shown, skirt 1830 is revealed, having an expanded,optionally frusto-conical configuration as shown. Delivery catheter 1840may exit out of a delivery lumen (not shown), with needle 1890 presentat the distal end of delivery catheter 1840. As shown in the embodimentof FIG. 20A, lead 1900 is present, exiting out of an aperture of needle1890.

FIGS. 20B and 20C show a closer view of an embodiment of a portion of anapparatus for engaging a tissue according to the present disclosure thanis shown in FIG. 20A. As shown in FIGS. 20B and 20C, aperture 1920 ofneedle 1890 is shown, and as shown in FIG. 20C, lead 1900 may exitaperture 1920 of needle 1890.

Referring now to FIGS. 5A, 5B, 5C, and 5D, there is shown anotherembodiment of an engagement catheter as disclosed herein. Engagementcatheter 700 is an elongated tube having a proximal end 710 and a distalend 720, as well as two lumens 730, 740 extending between proximal end710 and distal end 720. Lumens 730, 740 are formed by concentric innerwall 750 and outer wall 760, as particularly shown in FIGS. 5B and 5C.At proximal end 710, engagement catheter 700 includes a vacuum port 770,which is attached to lumen 730 so that a vacuum source can be attachedto vacuum port 770 to create suction in lumen 730, thereby forming asuction channel. At distal end 720 of catheter 700, a suction port 780is attached to lumen 730 so that suction port 780 can be placed incontact with heart tissue 775 (see FIG. 5D) for aspirating the tissue,thereby forming a vacuum seal between suction port 780 and tissue 775when the vacuum source is attached and engaged. The vacuum seal enablessuction port 780 to grip, stabilize, and retract tissue 775. Forexample, attaching a suction port to an interior atrial wall using avacuum source enables the suction port to retract the atrial wall fromthe pericardial sac surrounding the heart, which enlarges thepericardial space between the atrial wall and the pericardial sac.

As shown in FIG. 5C, two internal lumen supports 810, 820 are locatedwithin lumen 730 and are attached to inner wall 750 and outer wall 760to provide support to the walls. These lumen supports divide lumen 730into two suction channels. Although internal lumen supports 810, 820extend from distal end 720 of catheter 700 along a substantial portionof the length of catheter 700, internal lumen supports 810, 820 may ormay not span the entire length of catheter 700. Indeed, as shown inFIGS. 5A, 5B, and 5C, internal lumen supports 810, 820 do not extend toproximal end 710 to ensure that the suction from the external vacuumsource is distributed relatively evenly around the circumference ofcatheter 700. Although the embodiment shown in FIG. 5C includes twointernal lumen supports, other embodiments may have just one internalsupport or even three or more such supports.

FIG. 5D shows engagement catheter 700 approaching heart tissue 775 forattachment thereto. It is important for the clinician performing theprocedure to know when the suction port has engaged the tissue of theatrial wall or the atrial appendage. For example, in reference to FIG.5D, it is clear that suction port 780 has not fully engaged tissue 775such that a seal is formed. However, because suction port 780 is notusually seen during the procedure, the clinician may determine when theproper vacuum seal between the atrial tissue and the suction port hasbeen made by monitoring the amount of blood that is aspirated, bymonitoring the suction pressure with a pressure sensor/regulator, orboth. For example, as engagement catheter 700 approaches the atrial walltissue (such as tissue 775) and is approximately in position, thesuction can be activated through lumen 730. A certain level of suction(e.g., 10 mmHg) can be imposed and measured with a pressuresensor/regulator. As long as catheter 700 does not engage the wall, someblood will be aspirated into the catheter and the suction pressure willremain the same. However, when catheter 700 engages or attaches to thewall of the heart (depicted as tissue 775 in FIG. 5D), minimal blood isaspirated and the suction pressure will start to gradually increase.Each of these signs can alert the clinician (through alarm or othermeans) as an indication of engagement. The pressure regulator is thenable to maintain the suction pressure at a preset value to preventover-suction of the tissue.

An engagement catheter, such as engagement catheter 700, may beconfigured to deliver a fluid or other substance to tissue on the insideof a wall of the heart, including an atrial wall or a ventricle wall.For example, lumen 740 shown in FIGS. 5A and 5C includes an injectionchannel 790 at distal end 720. Injection channel 790 dispenses to thetargeted tissue a substance flowing through lumen 740. As shown in FIG.5D, injection channel 790 is the distal end of lumen 740. However, inother embodiments, the injection channel may be ring-shaped (see FIG.2C) or have some other suitable configuration.

Substances that can be locally administered with an engagement catheterinclude preparations for gene or cell therapy, drugs, and adhesives thatare safe for use in the heart. The proximal end of lumen 740 has a fluidport 800, which is capable of attachment to an external fluid source forsupply of the fluid to be delivered to the targeted tissue. Indeed,after withdrawal of a needle from the targeted tissue, as discussedherein, an adhesive may be administered to the targeted tissue by theengagement catheter for sealing the puncture wound left by the needlewithdrawn from the targeted tissue.

Referring now to FIGS. 6A, 6B, and 6C, there is shown a deliverycatheter 850 comprising an elongated hollow tube 880 having a proximalend 860, a distal end 870, and a lumen 885 along the length of thecatheter. Extending from distal end 870 is a hollow needle 890 incommunication with lumen 885. Needle 890 is attached to distal end 870in the embodiment of FIGS. 6A, 6B, and 6C, but, in other embodiments,the needle may be removably attached to, or otherwise located at, thedistal end of the catheter (see FIG. 1A). In the embodiment shown inFIGS. 6A, 6B, and 6C, as in certain other embodiments having an attachedneedle, the junction (i.e., site of attachment) between hollow tube 880and needle 890 forms a security notch 910 circumferentially aroundneedle 890 to prevent needle 890 from over-perforation. Thus, when aclinician inserts needle 890 through an atrial wall to gain access tothe pericardial space, the clinician will not, under normal conditions,unintentionally perforate the pericardial sac with needle 890 becausethe larger diameter of hollow tube 880 (as compared to that of needle890) at security notch 910 hinders further needle insertion. Althoughsecurity notch 910 is formed by the junction of hollow tube 880 andneedle 890 in the embodiment shown in FIGS. 6A, 6B, and 6C, otherembodiments may have a security notch that is configured differently.For example, a security notch may include a band, ring, or similardevice that is attached to the needle a suitable distance from the tipof the needle. Like security notch 910, other security notch embodimentshinder insertion of the needle past the notch itself by presenting alarger profile than the profile of the needle such that the notch doesnot easily enter the hole in the tissue caused by entry of the needle.

It is useful for the clinician performing the procedure to know when theneedle has punctured the atrial tissue. This can be done in severalways. For example, the delivery catheter can be connected to a pressuretransducer to measure pressure at the tip of the needle. Because thepressure is lower and much less pulsatile in the pericardial space thanin the atrium, the clinician can recognize immediately when the needlepasses through the atrial tissue into the pericardial space.

Alternatively, as shown in FIG. 6B, needle 890 may be connected to astrain gauge 915 as part of the catheter assembly. When needle 890contacts tissue (not shown), needle 890 will be deformed. Thedeformation will be transmitted to strain gauge 915 and an electricalsignal will reflect the deformation (through a classical wheatstonebridge), thereby alerting the clinician. Such confirmation of thepuncture of the wall can prevent over-puncture and can provideadditional control of the procedure.

In some embodiments, a delivery catheter, such as catheter 850 shown inFIGS. 6A, 6B, and 6C, is used with an engagement catheter, such ascatheter 700 shown in FIGS. 5A, 5B, 5C, and 5D, to gain access to thepericardial space between the heart wall and the pericardial sac. Forexample, engagement catheter 700 may be inserted into the vascularsystem and advanced such that the distal end of the engagement catheteris within the atrium. The engagement catheter may be attached to thetargeted tissue on the interior of a wall of the atrium using a suctionport as disclosed herein. A standard guide wire may be inserted throughthe lumen of the delivery catheter as the delivery catheter is insertedthrough the inner lumen of the engagement catheter, such as lumen 740shown in FIGS. 5B and 5C. Use of the guide wire enables more effectivenavigation of the delivery catheter 850 and prevents the needle 890 fromdamaging the inner wall 750 of the engagement catheter 700. When the tipof the delivery catheter with the protruding guide wire reaches theatrium, the wire is pulled back, and the needle is pushed forward toperforate the targeted tissue. The guide wire is then advanced throughthe perforation into the pericardial space, providing access to thepericardial space through the atrial wall.

Referring again to FIGS. 6A, 6B, and 6C, lumen 885 of delivery catheter850 may be used for delivering fluid into the pericardial space afterneedle 890 is inserted through the atrial wall or the atrial appendage.After puncture of the wall or appendage, a guide wire (not shown) may beinserted through needle lumen 900 into the pericardial space to maintainaccess through the atrial wall or appendage. Fluid may then beintroduced to the pericardial space in a number of ways. For example,after the needle punctures the atrial wall or appendage, the needle isgenerally withdrawn. If the needle is permanently attached to thedelivery catheter, as in the embodiment shown in FIGS. 6A and 6B, thendelivery catheter 850 would be withdrawn and another delivery catheter(without an attached needle) would be introduced over the guide wireinto the pericardial space. Fluid may then be introduced into thepericardial space through the lumen of the second delivery catheter.

In some embodiments, however, only a single delivery catheter is used.In such embodiments, the needle is not attached to the deliverycatheter, but instead may be a needle wire (see FIG. 1A). In suchembodiments, the needle is withdrawn through the lumen of the deliverycatheter, and the delivery catheter may be inserted over the guide wireinto the pericardial space. Fluid is then introduced into thepericardial space through the lumen of the delivery catheter.

The various embodiments disclosed herein may be used by clinicians, forexample: (1) to deliver genes, cells, drugs, etc.; (2) to providecatheter access for epicardial stimulation; (3) to evacuate fluidsacutely (e.g., in cases of pericardial tampondae) or chronically (e.g.,to alleviate effusion caused by chronic renal disease, cancer, etc.);(4) to perform transeptal puncture and delivery of a catheter throughthe left atrial appendage for electrophysiological therapy, biopsy,etc.; (5) to deliver a magnetic glue or ring through the right atrialappendage to the aortic root to hold a percutaneous aortic valve inplace; (6) to deliver a catheter for tissue ablation, e.g., to thepulmonary veins, or right atrial and epicardial surface of the heart foratrial and ventricular arrythmias; (7) to deliver and place epicardial,right atrial, and right and left ventricle pacing leads (as discussedherein); (8) to occlude the left atrial appendage through percutaneousapproach; and (9) to visualize the pericardial space with endo-camera orscope to navigate the epicardial surface of the heart for therapeuticdelivery, diagnosis, lead placement, mapping, etc. Many otherapplications, not explicitly listed here, are also possible and withinthe scope of the present disclosure.

Referring now to FIG. 7, there is shown a delivery catheter 1000.Delivery catheter 1000 includes an elongated tube 1010 having a wall1020 extending from a proximal end (not shown) of tube 1010 to a distalend 1025 of tube 1010. Tube 1010 includes two lumens, but otherembodiments of delivery catheters may have fewer than, or more than, twolumens, depending on the intended use of the delivery catheter. Tube1010 also includes a steering channel 1030, in which a portion ofsteering wire system 1040 is located. Steering channel 1030 formsorifice 1044 at distal end 1025 of tube 1010 and is sized to fit over aguide wire 1050.

FIG. 8 shows in more detail steering wire system 1040 within steeringchannel 1030 (which is shown cut away from the remainder of the deliverycatheter). Steering wire system 1040 is partially located in steeringchannel 1030 and comprises two steering wires 1060 and 1070 and acontroller 1080, which, in the embodiment shown in FIG. 8, comprises afirst handle 1090 and a second handle 1094. First handle 1090 isattached to proximal end 1064 of steering wire 1060, and second handle1094 is attached to proximal end 1074 of steering wire 1070. Distal end1066 of steering wire 1060 is attached to the wall of the tube of thedelivery catheter within steering channel 1030 at attachment 1100, anddistal end 1076 of steering wire 1070 is attached to the wall of thetube of the delivery catheter within steering channel 1030 at attachment1110. As shown in FIG. 7, attachment 1100 and attachment 1110 arelocated on opposing sides of steering channel 1030 near distal tip 1120of delivery catheter 1000.

In the embodiment of FIG. 8, steering wires 1060 and 1070 are threadedas a group through steering channel 1030. However, the steering wiresystems of other embodiments may include steering wires that areindividually threaded through smaller lumens within the steeringchannel. For example, FIG. 11 shows a cross-sectional view of a deliverycatheter 1260 having an elongated tube 1264 comprising a wall 1266, asteering channel 1290, a first lumen 1270, and a second lumen 1280.Delivery catheter 1260 further includes a steering wire 1292 within asteering wire lumen 1293, a steering wire 1294 within a steering wirelumen 1295, and a steering wire 1296 within a steering wire lumen 1297.Each of steering wire lumens 1293, 1295, and 1297 is located withinsteering channel 1290 and is formed from wall 1266. Each of steeringwires 1292, 1294, and 1296 is attached to wall 1266 within steeringchannel 1290. As will be explained, the attachment of each steering wireto the wall may be located near the distal tip of the delivery catheter,or may be located closer to the middle of the delivery catheter.

Referring now to FIGS. 7 and 8, steering wire system 1040 can be used tocontrol distal tip 1120 of delivery catheter 1000. For example, whenfirst handle 1090 is pulled, steering wire 1060 pulls distal tip 1120,which bends delivery catheter 1000, causing tip deflection in a firstdirection. Similarly, when second handle 1094 is pulled, steering wire1070 pulls distal tip 1120 in the opposite direction, which bendsdelivery catheter 1000, causing tip deflection in the oppositedirection. Thus, delivery catheter 1000 can be directed (i.e., steered)through the body using steering wire system 1040.

Although steering wire system 1040 has only two steering wires, otherembodiments of steering wire systems may have more than two steeringwires. For example, some embodiments of steering wire systems may havethree steering wires (see FIG. 11), each of which is attached to thesteering channel at a different attachment. Other embodiments ofsteering wire systems may have four steering wires. Generally, moresteering wires give the clinician more control for directing thedelivery catheter because each additional steering wire enables the userto deflect the tip of the delivery catheter in an additional direction.For example, four steering wires could be used to direct the deliverycatheter in four different directions (e.g., up, down, right, and left).

If a steering wire system includes more than two steering wires, thedelivery catheter may be deflected at different points in the samedirection. For instance, a delivery catheter with three steering wiresmay include two steering wires for deflection in a certain direction anda third steering wire for reverse deflection (i.e., deflection in theopposite direction). In such an embodiment, the two steering wires fordeflection are attached at different locations along the length of thedelivery catheter. Referring now to FIGS. 9A-9C, there is shown asteering wire system 1350 within steering channel 1360 (which is showncut away from the remainder of the delivery catheter) in differentstates of deflection. Steering wire system 1350 is partially located insteering channel 1360 and comprises three steering wires 1370, 1380, and1390 and a controller 1400, which, in the embodiment shown in FIGS.9A-9C, comprises a handle 1405. Handle 1405 is attached to proximal end1374 of steering wire 1370, proximal end 1384 of steering wire 1380, andproximal end 1394 of steering wire 1390. Distal end 1376 of steeringwire 1370 is attached to the wall of the tube of the delivery catheterwithin steering channel 1360 at attachment 1378, which is near thedistal tip of the delivery catheter (not shown). Distal end 1386 ofsteering wire 1380 is attached to the wall of the tube of the deliverycatheter within steering channel 1360 at attachment 1388, which is nearthe distal tip of the delivery catheter (not shown). Attachment 1378 andattachment 1388 are located on opposing sides of steering channel 1360such that steering wires 1370 and 1380, when tightened (as explainedbelow), would tend to deflect the delivery catheter in oppositedirections. Distal end 1396 of steering wire 1390 is attached to thewall of the tube of the delivery catheter within steering channel 1360at attachment 1398, which is located on the delivery catheter at a pointcloser to the proximal end of the delivery catheter than attachments1378 and 1388. Attachment 1398 is located on the same side of steeringchannel 1360 as attachment 1388, such that steering wires 1380 and 1390,when tightened (as explained below), would tend to deflect the deliverycatheter in the same direction. However, because attachment 1398 iscloser to the proximal end of the delivery catheter than is attachment1388, the tightening of steering wire 1390 tends to deflect the deliverycatheter at a point closer to the proximal end of the delivery catheterthan does the tightening of steering wire 1380. Thus, as shown in FIG.9A, the tightening of steering wire 1390 causes a deflection in thedelivery catheter approximately at point 1410. The tightening ofsteering wire 1380 at the same time causes a further deflection in thedelivery catheter approximately at point 1420, as shown in FIG. 9B. Thetightening of steering wire 1370, therefore, causes a reversedeflection, returning the delivery catheter to its original position(see FIG. 9C).

Referring again to FIG. 7, elongated tube 1010 further includes lumen1130 and lumen 1140. Lumen 1130 extends from approximately the proximalend (not shown) of tube 1010 to or near distal end 1025 of tube 1010.Lumen 1130 has a bend 1134, relative to tube 1010, at or near distal end1025 of tube 1010 and an outlet 1136 through wall 1020 of tube 1010 ator near distal end 1025 of tube 1010. Similarly, lumen 1140 has a bend1144, relative to tube 1010, at or near distal end 1025 of tube 1010 andan outlet 1146 through wall 1020 of tube 1010 at or near distal end 1025of tube 1010. In the embodiment shown in FIG. 7, lumen 1130 isconfigured as a laser Doppler tip, and lumen 1140 is sized to accept aretractable sensing lead 1150 and a pacing lead 1160 having a tip at thedistal end of the lead. The fiberoptic laser Doppler tip detects andmeasures blood flow (by measuring the change in wavelength of lightemitted by the tip), which helps the clinician to identify—and thenavoid—blood vessels during lead placement. Sensing lead 1150 is designedto detect electrical signals in the heart tissue so that the cliniciancan avoid placing a pacing lead into electrically nonresponsive tissue,such as scar tissue. Pacing lead 1160 is a screw-type lead for placementonto the cardiac tissue, and its tip, which is an electrode, has asubstantially screw-like shape. Pacing lead 1160 is capable of operativeattachment to a CRT device (not shown) for heart pacing. Although lead1160 is used for cardiac pacing, any suitable types of leads may be usedwith the delivery catheters described herein, including sensing leads.

Each of bend 1134 of lumen 1130 and bend 1144 of lumen 1140 forms anapproximately 90-degree angle, which allows respective outlets 1136 and1146 to face the external surface of the heart as the catheter ismaneuvered in the pericardial space. However, other embodiments may havebends forming other angles, smaller or larger than 90-degrees, so longas the lumen provides proper access to the external surface of the heartfrom the pericardial space. Such angles may range, for example, fromabout 25-degrees to about 155-degrees. In addition to delivering leadsand Doppler tips, lumen 1130 and lumen 1140 may be configured to allow,for example, the taking of a cardiac biopsy, the delivery of gene celltreatment or pharmacological agents, the delivery of biological glue forventricular reinforcement, implementation of ventricular epicardialsuction in the acute myocardial infarction and border zone area, theremoval of fluid in treatment of pericardial effusion or cardiactamponade, or the ablation of cardiac tissue in treatment of atrialfibrillation.

For example, lumen 1130 could be used to deliver a catheter needle forintramyocardial injection of gene cells, stems, biomaterials, growthfactors (such as cytokinase, fibroblast growth factor, or vascularendothelial growth factor) and/or biodegradable synthetic polymers,RGD-liposome biologic glue, or any other suitable drug or substance fortreatment or diagnosis. For example, suitable biodegradable syntheticpolymer may include polylactides, polyglycolides, polycaprolactones,polyanhydrides, polyamides, and polyurethanes. In certain embodiments,the substance comprises a tissue inhibitor, such as a metalloproteinase(e.g., metalloproteinase 1).

The injection of certain substances (such as biopolymers andRGD-liposome biologic glue) is useful in the treatment of chronic heartfailure to reinforce and strengthen the left ventricular wall. Thus,using the embodiments disclosed herein, the injection of such substancesinto the cardiac tissue from the pericardial space alleviates theproblems and risks associated with delivery via the transthoracicapproach. For instance, once the distal end of the delivery catheter isadvanced to the pericardial space, as disclosed herein, a needle isextended through a lumen of the delivery catheter into the cardiactissue and the substance is injected through the needle into the cardiactissue.

The delivery of substances into the cardiac tissue from the pericardialspace can be facilitated using a laser Doppler tip. For example, whentreating ventricular wall thinning, the laser Doppler tip located inlumen 1140 of the embodiment shown in FIG. 7 can be used to measure thethickness of the left ventricular wall during the procedure (in realtime) to determine the appropriate target area for injection.

Referring again to FIG. 8, although controller 1080 comprises firsthandle 1090 and second handle 1094, other embodiments of the controllermay include different configurations. For example, instead of usinghandles, a controller may include any suitable torque system forcontrolling the steering wires of the steering wire system. Referringnow to FIG. 10, there is shown a portion of a steering wire system 1170having steering wire 1180, steering wire 1190, and controller 1200.Controller 1200 comprises a torque system 1210 having a first rotatablespool 1220, which is capable of collecting and dispensing steering wire1180 upon rotation. For example, when first rotatable spool 1220 rotatesin a certain direction, steering wire 1180 is collected onto spool 1220,thereby tightening steering wire 1180. When spool 1220 rotates in theopposite direction, steering wire 1180 is dispensed from spool 1220,thereby loosening steering wire 1180. Torque system 1210 also has asecond rotatable spool 1230, which is capable of collecting anddispensing steering wire 1190 upon rotation, as described above.

Torque system 1210 further includes a first rotatable dial 1240 and asecond rotatable dial 1250. First rotatable dial 1240 is attached tofirst rotatable spool 1220 such that rotation of first rotatable dial1240 causes rotation of first rotatable spool 1220. Similarly, secondrotatable dial 1250 is attached to second rotatable spool 1230 such thatrotation of second rotatable dial 1250 causes rotation of secondrotatable spool 1230. For ease of manipulation of the catheter, torquesystem 1210, and specifically first and second rotatable dials 1240 and1250, may optionally be positioned on a catheter handle (not shown) atthe proximal end of tube 1010.

Steering wire system 1170 can be used to direct a delivery catheterthrough the body in a similar fashion as steering wire system 1140.Thus, for example, when first rotatable dial 1240 is rotated in a firstdirection (e.g., clockwise), steering wire 1180 is tightened and thedelivery catheter is deflected in a certain direction. When firstrotatable dial 1240 is rotated in the other direction (e.g.,counterclockwise), steering wire 1180 is loosened and the deliverycatheter straightens to its original position. When second rotatabledial 1250 is rotated in one direction (e.g., counterclockwise), steeringwire 1190 is tightened and the delivery catheter is deflected in adirection opposite of the first deflection. When second rotatable dial1250 is rotated in the other direction (e.g., clockwise), steering wire1190 is loosened and the delivery catheter is straightened to itsoriginal position.

Certain other embodiments of steering wire system may comprise othertypes of torque system, so long as the torque system permits theclinician to reliably tighten and loosen the various steering wires. Themagnitude of tightening and loosening of each steering wire should becontrollable by the torque system.

Referring again to FIG. 11, there is shown a cross-sectional view ofdelivery catheter 1260. Delivery catheter 1260 includes tube 1265, afirst lumen 1270, a second lumen 1280, and a steering channel 1290.Steering wires 1292, 1294, and 1296 are shown within steering channel1290. First lumen 1270 has outlet 1275, which can be used to deliver amicro-camera system (not shown) or a laser Doppler tip 1278. Secondlumen 1280 is sized to deliver a pacing lead 1300, as well as a sensinglead (not shown).

Treatment of cardiac tamponade, by the removal of a pericardialeffusion, may be accomplished using an apparatus of the presentdisclosure as described below. A typical procedure would involve thepercutaneous intravascular insertion of a portion of an apparatus into abody, which can be performed under local or general anesthesia. Aportion of the apparatus may then utilize an approach described hereinor otherwise known by a user of the apparatus to enter the percutaneousintravascular pericardial sac. It can be appreciated that such anapparatus may be used to access other spaces within a body to removefluid and/or deliver a gas, liquid, and/or particulate(s) as describedherein, and that such an apparatus is not limited to heart access andremoval of pericardial effusions.

Exemplary embodiments of a portion of such an apparatus are shown inFIGS. 21A and 21B. As shown in FIG. 21A, a perforated drainage catheter2100 is provided. Perforated drainage catheter 2100 comprises a tubedefining at least one suction/infusion aperture 2110, and as shown inthe embodiment in FIG. 21A, perforated drainage catheter 2100 definesmultiple suction/infusion apertures 2110. Suction/infusion apertures2110 are operably connected to an internal lumen defined withinperforated delivery catheter 2100. It can be appreciated that theportion of perforated drainage catheter 2100 as shown in FIGS. 21A and21B may be coupled to one or more portions of a system for engaging atissue as described herein. As such, one or more portions of a systemfor engaging a tissue may be used to define a system for removing fluidas described herein.

It can be appreciated that the internal lumen within perforated deliverycatheter 2100 may define multiple internal channels. For example,perforated delivery catheter 2100 may define two channels, one channeloperably coupled to one or more suction/infusion apertures 2110 to allowfor a vacuum source coupled to one end of the channel to provide suctionvia the suction/infusion apertures 2110, and one channel operablycoupled to one or more other suction/infusion channels to allow for theinjection of gas, liquid, and/or particulate(s) to a target site.

As described in further detail below, when perforated drainage catheter2100 enters a space in a body, for example a pericardial sac, perforateddrainage catheter 2100 may be used to remove fluid by the use of suctionthrough one or more suction/infusion apertures 2110. Perforated drainagecatheter 2100 may also be used to deliver gas, liquid, and/orparticulate(s) to a target site through one or more suction/infusionapertures 2110.

Another exemplary embodiment of a portion of a perforated drainagecatheter 2100 is shown in FIG. 21B. As shown in FIG. 21B, perforateddrainage catheter 2100 comprises a tube with multiple suction/infusionapertures 2110. However, in this exemplary embodiment, perforateddrainage catheter 2100 comprises a number of concave grooves 2120extending a portion of a length of perforated drainage catheter 2100,whereby the suction/infusion apertures 2110 are provided at the recessedportions therein. Concave grooves 2120, when positioned at leastpartially around the circumference of perforated drainage catheter 2100,define one or more ridges 2130 extending a portion of a length ofperforated drainage catheter 2100. Said ridges 2130 of perforateddrainage catheter 2100, when positioned at or near a tissue (not shown),aid to prevent a tissue from coming in direct contact with one or moresuction/infusion apertures 2110. For example, when perforated drainagecatheter 2100 is used in a manner described herein and when a vacuum iscoupled to perforated drainage catheter 2100, suction from one or moresuction/infusion apertures 2110 positioned within one or more concavegrooves 2120 would allow for the removal of fluid present in the area ofperforated drainage catheter 2100. Ridges 2130 would aid to prevent orminimize tissue adhesion and/or contact with the one or moresuction/infusion apertures 2110.

A procedure using perforated drainage catheter 2100 may be performed byinserting perforated drainage catheter 2100 into a pericardial sac,following the cardiac surface using, for example, fluoroscopy and/orechodoppler visualization techniques. When perforated drainage catheter2100 is inserted into a pericardial sac, a pericardial effusion presentwithin the pericardial sac, may be removed by, for example, gentlesuction using a syringe. In one example, a 60 cc syringe may be used toremove the effusion with manual gentle suction. When the effusion hasbeen removed, the patients hemodynamic parameters may be monitored todetermine the effectiveness of the removal of the effusion. When thepericardial sac is empty, determined by, for example, fluoroscopy orechodoppler visualization, the acute pericardial effusion catheter maybe removed, or it may be used for local treatment to introduce, forexample, an antibiotic, chemotherapy, or another drug as describedbelow.

An exemplary embodiment of a portion of a perforated drainage catheter2100 present within a pericardial sac is shown in FIG. 22. As shown inFIG. 22, perforated drainage catheter 2100 is first inserted into theheart 2200 using one or more of the techniques and/or proceduresdescribed herein, and is placed through the right atrial appendage 2210,the visceral pericardium 2215, and into the pericardial sac 2220. Theouter portion of the pericardial sac 2220 is defined by the parietalpericardium 2230. A pericardial effusion 2240 (fluid within thepericardial sac 2220) may then be removed using perforated drainagecatheter 2100. When a vacuum source (not shown) is coupled to theproximal end of a portion of a system for removing fluid (comprising, inpart, perforated drainage catheter 2100 and one or more other componentsof a system for engaging a tissue as described herein), the introductionof a vacuum to perforated drainage catheter 2100 allows the pericardialeffusion 2240 (the fluid) to be withdrawn from the pericardial sac 2220into one or more suction/infusion apertures 2110 defined along a lengthof suction/infusion apertures 2110.

When perforated drainage catheter 2100 is used to remove some or all ofa pericardial effusion (or other fluid present within a space within abody), it may also be used to deliver a gas, liquid, and/orparticulate(s) at or near the space where the fluid was removed. Forexample, the use of perforated drainage catheter 2100 to remove apericardial effusion may increase the risk of infection. As such,perforated drainage catheter 2100 may be used to rinse the pericardialsac (or other space present within a body) with water and/or any numberof beneficial solutions, and may also be used to deliver one or moreantibiotics to provide an effective systemic antibiotic therapy for thepatient. While the intrapericardial instillation of antibiotics (e.g.,gentamycin) is useful, it is typically not sufficient by itself, and assuch, it may be combined with general antibiotics treatment for a moreeffective treatment.

Additional methods to treat neoplastic pericardial effusions withouttamponade may be utilized using a device, system and/or method of thepresent disclosure. For example, a systemic antineoplastic treatment maybe performed to introduce drugs to inhibit and/or prevent thedevelopment of tumors. If a non-emergency condition exists (e.g., not acardiac tamponade), a system and/or method of the present disclosure maybe used to perform a pericardiocentesis. In addition, the presentdisclosure allows for the intrapericardial instillation of acytostatic/sclerosing agent. It can be appreciated that using one ormore of the devices, systems and/or methods disclosed herein, theprevention of recurrences may be achieved by intrapericardialinstillation of sclerosing agents, cytotoxic agents, orimmunomodulators, noting that the intrapericardial treatment may betailored to the type of the tumor. Regarding chronic autoreactivepericardial effusions, the intrapericardial instillation of crystalloidglucocorticoids could avoid systemic side effects, while still allowinghigh local dose application.

A pacing lead may be placed on the external surface of the heart usingan engagement catheter and a delivery catheter as disclosed herein. Forexample, an elongated tube of an engagement catheter is extended into ablood vessel so that the distal end of the tube is in contact with atargeted tissue on the interior of a wall of the heart. As explainedabove, the targeted tissue may be on the interior of the atrial wall orthe atrial appendage. Suction is initiated to aspirate a portion of thetargeted tissue to retract the cardiac wall away from the pericardialsac that surrounds the heart, thereby enlarging a pericardial spacebetween the pericardial sac and the cardiac wall. A needle is theninserted through a lumen of the tube and advanced to the heart. Theneedle is inserted into the targeted tissue, causing a perforation ofthe targeted tissue. The distal end of a guide wire is inserted throughthe needle into the pericardial space to secure the point of entrythrough the cardiac wall. The needle is then withdrawn from the targetedtissue.

A delivery catheter, as described herein, is inserted into the lumen ofthe tube of the engagement catheter and over the guide wire. Thedelivery catheter may be a 14 Fr. radiopaque steering catheter. Thedistal end of the delivery catheter is advanced over the guide wirethrough the targeted tissue into the pericardial space. Once in thepericardial space, the delivery catheter is directed using a steeringwire system as disclosed herein. In addition, a micro-camera system maybe extended through the lumen of the delivery catheter to assist in thedirection of the delivery catheter to the desired location in thepericardial space. Micro-camera systems suitable for use with thedelivery catheter are well-known in the art. Further, a laser Dopplersystem may be extended through the lumen of the delivery catheter toassist in the direction of the delivery catheter. The delivery catheteris positioned such that the outlet of one of the lumens of the deliverycatheter is adjacent to the external surface of the heart (e.g., theexternal surface of an atrium or a ventricle). A pacing lead is extendedthrough the lumen of the delivery catheter onto the external surface ofthe heart. The pacing lead may be attached to the external surface ofthe heart, for example, by screwing the lead into the cardiac tissue. Inaddition, the pacing lead may be placed deeper into the cardiac tissue,for example in the subendocardial tissue, by screwing the lead furtherinto the tissue. After the lead is placed in the proper position, thedelivery catheter is withdrawn from the pericardial space and the body.The guide wire is withdrawn from the pericardial space and the body, andthe engagement catheter is withdrawn from the body.

The disclosed embodiments can be used for subendocardial, as well asepicardial, pacing. While the placement of the leads is epicardial, theleads can be configured to have a long screw-like tip that reaches nearthe subendocardial wall. The tip of the lead can be made to beconducting and stimulatory to provide the pacing to the subendocardialregion. In general, the lead length can be selected to pace transmurallyat any site through the thickness of the heart wall. Those of skill inthe art can decide whether epicardial, subendocardial, or sometransmural location stimulation of the muscle is best for the patient inquestion.

An embodiment of a catheter apparatus to improve heart functionaccording to the present disclosure is shown in FIGS. 23A and 23B. Asshown in FIG. 23A, catheter apparatus 3100 comprises a suction/infusioncatheter 3102 and at least one balloon 3104 capable of inflation.Balloon 3104 may be coupled to a suction/inflation source 3106 viaconduit 3108 coupling balloon 3104 to suction/inflation source 3106. Inat least one embodiment, conduit 3108 comprises a tube positioned withina lumen 3110 of suction/infusion catheter 3102. In another embodiment,conduit 3108 comprises a tube positioned outside of suction/infusioncatheter 3102, but positioned proximally to suction/infusion catheter3102 so that suction/infusion catheter 3102 and conduit 3108 may bepositioned within a body in a similar manner. It can be appreciated thatconduit 3108 may also comprise a conduit positioned within a wall ofsuction/infusion catheter 3102, or may comprise a conduit coupled toeither or both an inner or outer wall of suction/infusion catheter 3102.

As shown in FIG. 23A, balloon 3104 is coupled to suction/infusioncatheter 3102. Balloon 3104 is shown in FIG. 23A in a deflated state,and is shown in an inflated state in the exemplary embodiment ofcatheter apparatus 3100 shown in FIG. 23B.

FIG. 23B shows an embodiment of catheter apparatus 3100 removablycoupled to an atrial wall 3112 of a heart. As shown in FIG. 23B,catheter apparatus 3100 may be positioned through an aperture in atrialwall 3112 and may be removably coupled to atrial wall 3112 by inflationand/or deflation of balloon 3104. As shown in FIG. 23B, catheterapparatus 3100 may be positioned within an atrial cavity 3114, throughatrial wall 3112, and into a pericardial space 3116, with the portion ofcatheter apparatus 3100 comprising balloon 3104 positioned at or nearthe atrial wall 3112. When positioned, inflation of balloon 3104 causesat least two portions of balloon 3104 to inflate, at least one portionof balloon 3104 inflating on either side of atrial wall 3112, or, in thealternative, inflation of balloon 3104 causes at least two balloons 3104to inflate, at least one balloon 3104 positioned on either side ofatrial wall 3112. When balloon 3104 is inflated, catheter apparatus 3100becomes removably coupled to atrial wall 3112 and held in place for aperiod of time desired by a user of catheter apparatus 3100. It can beappreciated that more than one balloon 3104, as described above, may becoupled to catheter apparatus 3100, with inflation of multiple balloonsoccurring after inflation from one or more suction/infusion sources3106. It can be further appreciated that catheter apparatus 3100 withballoon 3104 may be removably secured within an aperture of an atrialwall 3112 via inflation of balloon 3104 on substantially or fully on oneside of atrial wall 3104, and a ridge, protrusion, or some otherphysical structure coupled to catheter apparatus 3100 on the other sideof atrial wall 3112 may function to hold catheter apparatus 3100 inplace when balloon 3104 is inflated.

FIG. 24 shows an embodiment of suction/infusion catheter 3102 positionedwithin a pericardial space 3116 surrounding a heart 3200. As shown inFIG. 24, suction/infusion catheter 3102 is positioned within an apertureof atrial wall 3112 and held in place via inflation of balloon 3104 ofsuction/infusion catheter 3102. Suction/infusion catheter 3102 may thenbe used to inject a substance, remove a substance via suction, or both,to or from a target site or target sites within and/or surrounding aheart 3200. In at least one embodiment, insertion of suction/infusioncatheter 3102 is performed under local anesthesia.

FIGS. 25A and 25B show embodiments of a distal end of suction/infusioncatheter 3102. As shown in FIG. 25A, suction/infusion catheter 3102comprises at least one aperture 3300 positioned at or near the distalend of suction/infusion catheter 3102. As shown in the embodiment inFIGS. 25A and 25B, suction/infusion catheter 3102 defines multipleapertures 3300. Apertures 3300 are operably connected to an internallumen defined within suction/infusion catheter 3102. It can beappreciated that the portion of suction/infusion catheter 3102 as shownin FIGS. 25A and 25B may be coupled to one or more portions of acatheter apparatus 3100 as described herein.

The internal lumen within suction/infusion catheter 3102 may definemultiple internal channels. For example, suction/infusion catheter 3102may define two channels, one channel operably coupled to one or moreapertures 3300 to provide suction, and one channel operably coupled toone or more other apertures 3300 to allow for the injection of gas,liquid, and/or particulate(s) to a target site.

As described in further detail below, when suction/infusion catheter3102 enters a space in a body (a pericardial sac, for example),suction/infusion catheter 3102 may be used to remove fluid by the use ofsuction through one or more apertures 3300. Suction/infusion catheter3102 may also be used to deliver gas, liquid, and/or particulate(s) to atarget site through one or more apertures 3300.

An exemplary embodiment of a portion of a distal end of asuction/infusion catheter 3102 is shown in FIG. 25B. As shown in FIG.25B, suction/infusion catheter 3102 comprises a tube with multipleapertures 3300. However, in this exemplary embodiment, suction/infusioncatheter 3102 comprises a number of concave grooves 3302 extending aportion of a length of suction/infusion catheter 3102, whereby theapertures 3300 are provided at the recessed portions therein. Concavegrooves 3302, when positioned at least partially around thecircumference of suction/infusion catheter 3102, define one or moreridges 3304 extending a portion of a length of suction/infusion catheter3102. Said ridges 3304 of suction/infusion catheter 3102, whenpositioned at or near a tissue (not shown), aid to prevent a tissue fromcoming in direct contact with one or more apertures 3300.

An exemplary suction/infusion catheter 3102 may also comprise one ormore pressure/volume sensors 3306 as shown in FIGS. 25A and 25B.Pressure/volume sensors 3306 may provide pressure and/or volumedata/readings with respect to the amount of a gas (helium, for example)to be delivered to or from a pericardial sac 3116.

An embodiment of a heart assist device 3400 of the present disclosure isshown in FIG. 26. As shown in FIG. 26, heart assist device 3400comprises at least two electromagnetic plates 3402 coupled to a cardiacprocessor 3404. Cardiac processor 3404 may optionally be coupled to atleast one electromagnetic plate 3402 via one or more wires 3406 as shownin FIG. 26. Bladder 3408 is positioned at least partially betweenelectromagnetic plates 3402 and is either permanently or removablyattached to electromagnetic plates 3402. In at least one exemplaryembodiment, heart assist device 3400 comprises an electromagnetic plateand a non-electromagnetic plate. A cardiac processor 3404, which may be,for example, an electrocardiogram (EKG or ECG), operates to moveelectromagnetic plates 3402, wherein electromagnetic plates 3402 maymove apart and/or together in relation to one another. Aselectromagnetic plates 3402 move about one another, bladder 3408 mayinflate and/or deflate in relation to electromagnetic plates 3402.Bladder 3408 may comprise, for example, a polyurethane, a silastic, oranother material suitable for proper function of bladder 3408. Forexample, if electromagnetic plates 3402 move apart from one another,bladder 3408, attached to electromagnetic plates 3402, wouldexpand/inflate. Expansion/inflation of bladder 3408 may also befacilitated by a gas stored within reservoir 3410. In at least oneembodiment, helium is used as a gas, and is stored within reservoir3410.

The exemplary embodiment of heart assist device 3400 shown in FIG. 26shows heart assist device 3400 in a relatively compressed state,denoting a “systolic time” of a heart 3200. As shown by the two verticalarrows appearing on electromagnetic plates 3402, when eachelectromagnetic plate 3402 moves in the direction of the verticalarrows, bladder 3408 may become compressed/deflated, and suchcompression/deflation may operate to move a gas in the direction of thehorizontal arrow shown in FIG. 26 to suction/infusion catheter 3102 (orto a portion of a catheter apparatus 3100), whereby a gas may beexpelled from one or more apertures 3300 into a space surrounding aheart 3200. A valve 3412 may be optionally positioned between reservoir3410 and bladder 3408 to regulate the flow of a gas from reservoir 3410.In at least one embodiment, valve 3412 is a unilateral valve, regulatingthe flow of a gas from reservoir 3410 but not into reservoir 3410. Apressure/volume sensor 3306 may also be positioned along heart assistdevice 3400 to may provide pressure and/or volume data/readings withrespect to the amount of a gas (helium, for example) to be delivered toor from a pericardial sac 3116.

An exemplary heart assist device 3400 of the present disclosure may alsooptionally comprise a power supply 3414 (a battery or a rechargeablebattery, for example), to provide power to one or more features of heartassist device 3400, including, but not limited to, electromagneticplates 3402, cardiac processor 3404, and a storage device 3416. Powersupply 3414 and storage device 3416 may be coupled to cardiac processor,or may be coupled to other portions of heart assist device 3400 as maybe available to allow for operation of heart assist device 3400. In atleast one embodiment, power supply 3414 is positioned subcutaneouslywithin a pectoral area of a patient. Storage device 3416 may retainmeasurements (heart data) including, but not limited to, general heartsignals, emissions of signals, EKG systolic/diastolic time, heart rateventricular volume, contraction signals, heart wall thickness, etc. (theaforementioned list being indicative of at least one parameter of heartdata), and such measurements may be accessible by cardiac processor 3404to allow for specific operation of heart assist device 3400. Forexample, if a heart 3200 is pumping at a rate slower than desired,cardiac processor 3404 may operate to increase the rate of heart pumpingby increasing the rate of introduction and removal of a gas to and/orfrom a pericardial space 3116 as described herein, allowing heart assistdevice 3400 to function as a pacemaker. Conversely, if a heart 3200 ispumping at a rate faster than desired, cardiac processor 3404 mayoperate to decrease the rate of heart pumping by decreasing the rate ofintroduction and removal of a gas to and/or from a pericardial space3116 as described herein. Cardiac processor 3404 may operate in such amanner based upon measurements stored within storage device 3416. In atleast one embodiment, such operation is initiated following EKG signalsreceived by heart assist device 3400 as described herein. In anotherembodiment, such operation is based upon information provided to cardiacprocessor 3404 from pressure/volume sensors 3306.

Another embodiment of a heart assist device 3400 of the presentdisclosure is shown in FIG. 27. The exemplary embodiment of heart assistdevice 3400 shown in FIG. 27 may contain one or more elements as shownwithin the embodiment shown in FIG. 26, but is not limited to suchelements, and may contain more or fewer elements as desired for aparticular embodiment. For purposes of discussion of the exemplaryembodiment shown in FIG. 27, the elements contained with the exemplaryembodiment shown in FIG. 26 are also contained in the exemplaryembodiment shown in FIG. 27.

The exemplary embodiment of heart assist device 3400 shown in FIG. 27shows heart assist device 3400 in a relatively inflated state, denotinga “diastolic time” of a heart 3200. As shown by the two vertical arrowsappearing on electromagnetic plates 3402, when each electromagneticplate 3402 moves in the direction of the vertical arrows, bladder 3408may become inflated, and such inflation may operate to move a gas in thedirection of the horizontal arrow shown in FIG. 27 from suction/infusioncatheter 3102, whereby a gas may be removed from a space surrounding aheart 3200 via one or more apertures 3300 along suction/infusioncatheter 3102.

FIG. 28 shows an exemplary embodiment of a patient wearing a heartassist device 3400 of the present disclosure. As shown in FIG. 28,patient 3600 is wearing heart assist device 3400, wherein heart assistdevice 3400 is secured to patient 3600 using, for example, an optionalbelt 3602. As shown in FIG. 28, reservoir 3410 is positioned externallyto patient 3600. Heart assist device 3400 may operate in a similarfunction as described within FIGS. 26 and 27, whereby cardiac processor3404 operates heart assist device 3400 to pump a gas in to and out froma space surrounding a heart 3200 via suction/infusion catheter 3102 toassist the functionality of heart 3200. Such a heart assist device 3400may optimally be relatively small, lightweight, portable, rechargeable,and easy for a patient 3600 to carry.

FIG. 29A shows an embodiment of a suction/infusion catheter 3102 of acatheter apparatus 3100 positioned within a heart 3200, through anatrial wall 3112, and into a pericardial space 3116. Suction/infusioncatheter 3102 may be operable to introduce a gas (helium, for example),into pericardial space 3116, during “systolic time” as described herein.In systole, as determined by EKG, for example, the infusion of a gasfrom pericardial space 3116 is made to compress heart 3200 and reduceheart 3200 wall dimensions, resulting in a decrease in wall stress.During contraction of heart 3200 (“systolic time”), pericardial space3116 may partially fill with a gas, assisting heart 3200 with itscontraction. The synchronized compressive pressure by the gas in thepericardial space 3116 over heart 3200 during the systolic timereinforces the blood ejection from the ventricles of heart 3200.

A gas may be introduced into pericardial space 3116 as described withinthe description relating to FIG. 26 herein. Expansion of a pericardialspace 3116 using a gas exerts pressures on the various walls of heart3200 as shown by the arrows in FIG. 29A. Such an expansion may not onlyassist the heart 3200 with its contraction function, but may alsoprovide additional beneficial support to a pericardial wall.

FIG. 29B also shows an embodiment of a suction/infusion catheter 3102 ofa catheter apparatus 3100 positioned within a heart 3200, through anatrial wall 3112, and into a pericardial space 3116. Suction/infusioncatheter 3102 may be operable to introduce remove a gas (helium, forexample), from pericardial space 3116, during “diastolic time” asdescribed herein. In diastole, as determined by EKG, for example, theremoval of a gas from pericardial space 3116 is made to un-load heart3200 and increase myocardial flow, resulting in increased perfusion. Thedeflation of the pericardial space 3116 due to gas suction duringdiastolic time reduces the compressive pressure over the heart 3200 andfacilitates the expansion/filling of the chambers of heart 3200 withblood. A gas may be removed from pericardial space 3116 as describedwithin the description relating to FIG. 27 herein.

During expansion of heart 3200 (“diastolic time”), gas may partially orfully expel from pericardial space 3116, assisting heart 3200 with itsexpansion. Removal of gas from pericardial space 3116 assists theexpansion of an internal heart chamber as shown by the arrows in FIG.29B, noting that as gas is expelled from a pericardial space 3116, theinnermost pericardial wall would be pulled inward (as shown by thearrows), assisting with the expansion of a chamber of heart 3200 as itfills with blood. As such, pericardial space 3116 functions as a pumpbladder of heart 3200 using a catheter apparatus 3100 of the presentdisclosure. For example, the parietal pericardium and the visceralpericardium have pumping characteristics of a pump bladder, wherein agas inflates the pump bladder to provide a compressive pressure on heart3200 during systolic time and deflating the pump bladder by gas suctionduring diastolic time. Furthermore, the amount of gas may be increasedand/or decreased as desired according to hemodynamic parameters madeavailable to cardiac processor 3404.

FIGS. 30A and 30B show embodiments of a distal end of suction/infusioncatheter 3102 with a pericardial balloon 3700 coupled thereto. As shownin FIG. 30A, suction/infusion catheter 3102 comprises at least oneaperture 3300 positioned at or near the distal end of suction/infusioncatheter 3102. As shown in the embodiments in FIGS. 30A and 30B,suction/infusion catheter 3102 defines multiple apertures 3300.Apertures 3300 are operably connected to an internal lumen definedwithin suction/infusion catheter 3102. It can be appreciated that theportion of suction/infusion catheter 3102, as shown in FIGS. 30A and30B, may be coupled to one or more portions of a catheter apparatus 3100as described herein.

The exemplary embodiment of a suction/infusion catheter 3102 shown inFIG. 30A is shown with a deflated pericardial balloon 3700. In at leastone procedure wherein suction/infusion catheter 3102 is introduced intoa pericardial space 3116 surrounding a heart 3200, suction/infusioncatheter 3102 may have a deflated pericardial balloon 3700 coupledthereto, so that suction/infusion catheter 3102 may be more readilyinserted into the pericardial space 3116. As shown in the embodimentshown in FIG. 30B, suction/infusion catheter 3102 is shown with aninflated pericardial balloon 3700. In at least one procedure whereinsuction/infusion catheter 3102 is introduced into a pericardial space3116 surrounding a heart 3200, pericardial balloon 3700 may be inflatedby an inflation source, including, but not limited to, suction/inflationsource 3106. It can be appreciated that any number of inflation sourcesknown in the art may be used to inflate pericardial balloon 3700.

Pericardial balloon 3700 may comprise any material suitable for aparticular application, including, but not limited to, a polyurethanepericardial balloon 3700, and may comprise any number of inflatedpericardial balloon 3700 volumes, including, but not limited to, a 30 ccor a 40 cc pericardial balloon 3700.

FIGS. 31A and 31B show exemplary embodiments of suction/infusioncatheter 3102 positioned within the pericardial space 3116 surrounding aheart 3200. In the exemplary embodiment shown in FIG. 31A,suction/infusion catheter 3102 is shown positioned within an atrialappendage, through an atrial wall 3112, and into the pericardial space3116 surrounding the heart 3200. In this embodiment, suction/infusioncatheter 3102 comprises a pericardial balloon 3700 positioned at or nearthe distal end of suction/infusion catheter 3102, wherein pericardialballoon 3700 is deflated (during “diastolic time”). This exemplaryembodiment and other embodiments may be coupled to and become part of adevice and/or apparatus of the present disclosure.

As shown in FIG. 31B, an exemplary embodiment of a suction/infusioncatheter 3102 positioned within the pericardial space 3116 surrounding aheart 3200 is shown. In this exemplary embodiment, pericardial balloon3700 is shown positioned within the pericardial space 3116 surroundingheart 3200 with pericardial balloon 3700 inflated (during “systolictime”). Pericardial balloon 3700 may be inflated using suction/inflationsource 3106, or using another inflation source operably coupled to theinternal lumen of suction/infusion catheter 3102, wherein gas may beintroduced into the lumen of suction/infusion catheter by, for example,a suction/inflation source 3106 or another inflation source coupled tothe suction/infusion catheter 3102, to enter pericardial balloon 3700via the one or more apertures 3300 defined therethrough. In at least oneembodiment, a conduit (not shown) may be used to connectsuction/inflation source 3106 or another inflation source to pericardialballoon 3700 to facilitate inflation and/or deflation of pericardialballoon 3700. As will be provided in further detail herein, positioninga suction/infusion catheter 3102 within a specific area within thepericardial space 3116 surrounding the heart 3200 will allow forlocalized inflation and/or deflation of the pericardial balloon 3700,allowing the pericardial balloon 3700 to potentially contact theepiardial wall at or near a desired chamber of a heart 3200.

FIGS. 32A and 32B show exemplary embodiments of suction/infusioncatheters 3012 comprising pericardial balloons 3700 positioned withinthe pericardial space 3116 surrounding a heart 3200. A shown in FIG.32A, suction/infusion catheter 3102 is positioned through an aperture inthe atrial wall 3112 and into the pericardial space 3116 surrounding aheart 3200. In this embodiment, suction/infusion catheter 3102 ispositioned within the pericardial space 3116 near the left ventricle ofthe heart 3200. In this exemplary embodiment, pericardial balloon 3700may be inflated during systolic time of the heart 3200, facilitating aheart beat. For example, if a heart 3200 is damaged, and the leftventricle is unable to properly beat to pump blood, positioning asuction/infusion catheter 3102 within the pericardial space 3116 nearthe left ventricle of the heart 3200, and inflating the pericardialballoon during systolic time, the natural beat of the heart 3200 alongwith the inflation of pericardial balloon 3700 exerting pressure on theepicardial wall outside the left ventricle would facilitate a strongerheart beat, and thus overall heart 3200 function.

FIG. 32B shows an exemplary embodiment of a device/apparatus asdescribed herein comprising multiple suction/infusion catheters 3102. Inthis exemplary embodiment, two suction/infusion catheters 3102 areprovided, with each suction/infusion catheter 3102 comprising apericardial balloon 3700. It can be appreciated that a device/apparatusof the present disclosure may comprise any number and/or types ofcatheters, including, but not limited to, multiple suction/infusioncatheters 3102, as may be desired for a particular application.

In the exemplary embodiment shown in FIG. 32B, one suction/infusioncatheter 3102 is positioned within the pericardial space 3116 at or nearthe left ventricle of the heart 3200, and another suction/infusioncatheter 3102 is positioned within the pericardial space 3116 at or nearthe right ventricle of the heart 3200. An embodiment comprising two ormore suction/infusion catheters 3102 with pericardial balloons 3700allow for inflation and/or deflation of two pericardial balloons 3700either at the same time, allowing for “counterpulsation” of the twoballoons 3700 when inflated and/or deflated. As a pericardial balloon3700 positioned within a pericardial space 3116 is inflated, pericardialballoon 3700 may exert a pressure against the epicardial wall, with suchpressure facilitating the beating of a heart 3200.

Several advantages exist for a catheter system 3100 and heart assistdevice 3400 of the present disclosure, including non-blood contact (asat least a portion of catheter system 3100 would be positioned within apericardial space 3116 when in use), and that no intravascular powersource, pumps, and or valves are required. As portions of such asystem/device may be introduced to a patient 3600 under localanesthesia, as no formal/invasive surgical procedure is required,reducing risks of infection, embolism, bleeding, and material fatigue.

In addition, portions of a system/device are relatively easy to insertand remove, and as such a system/device does not require the use ofpharmaceuticals, no drug treatment contraindications would exist.Furthermore, as a reservoir 3410 would be positioned externally to thebody of a patient 3600, it may be completely rechargeable withoutpatient 3600 complication during the replacement period. Such asystem/device may also measure on line cardiac rhythm, ventricularvolumes displacements, pressure, etc., to tailor the treatment for aspecific patent 3600. Furthermore, such a system/device would allow apatient 3600 to be freely mobile without discomfort.

It can be appreciated that a heart assist device 3400 as describedherein may comprise other means of injecting and/or removing a gas froma pericardial space 3116. For example, and instead of using one or moreelectromagnetic plates 3402 and a bladder 3408, heart assist device mayinstead use a piston as the gas injection/removal mechanism, wherebysaid piston have the same effect in operation as the operation of aheart assist device using one or more electromagnetic plates 3402 and abladder 3408 as described herein.

The devices, systems, and methods of the present disclosure provide forhemodynamic control during a procedure as disclosed herein, utilizing,for example, mean arterial pressure, wedge pressure, central venouspressure, cardiac output, and cardiac index. Evaluation of ventricularfunction with echocardiograms, nuclear magnetic resonance (NMR), ormyocardial echo contrast, for example, may also be performed consistentwith the methods of the present disclosure. In addition to theforegoing, the present disclosure allows for easy insertion and removalof a suction/infusion catheter 2306.

While various embodiments of devices and methods for assisting heartfunction have been described in considerable detail herein, theembodiments are merely offered by way of non-limiting examples of thedisclosure described herein. It will therefore be understood thatvarious changes and modifications may be made, and equivalents may besubstituted for elements thereof, without departing from the scope ofthe disclosure. Indeed, this disclosure is not intended to be exhaustiveor to limit the scope of the disclosure.

Further, in describing representative embodiments, the disclosure mayhave presented a method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described.Other sequences of steps may be possible. Therefore, the particularorder of the steps disclosed herein should not be construed aslimitations of the present disclosure. In addition, disclosure directedto a method and/or process should not be limited to the performance oftheir steps in the order written. Such sequences may be varied and stillremain within the scope of the present disclosure.

1. A device for assisting heart function, comprising: at least twoelectromagnetic plates, the at least two electromagnetic plates havingan inner surface; a cardiac processor electrically coupled to at leastone of the at least two electromagnetic plates; a bladder having aninner chamber, the bladder attached to the inner surfaces of each of theat least two electromagnetic plates and disposed between the at leasttwo electromagnetic plates; a source of gas in communication with theinner chamber of the bladder; and at least one catheter having aproximal end and a distal end and having a lumen therethrough, the atleast one catheter defining at least one aperture positionedtherethrough at or near the distal end of the at least one catheter andcomprising a first pericardial balloon coupled to the at least onecatheter at or near the distal end of the at least one catheter, theproximal end of the at least one catheter in communication with theinner chamber of the bladder.
 2. The device of claim 1, wherein when thedistal end of the at least one catheter is positioned within apericardial space, the device operates to inject gas into and/or removegas from the first pericardial balloon.
 3. The device of claim 1,wherein the at least two electromagnetic plates are operable to compressthe bladder, wherein the compression of the bladder injects gas into thefirst pericardial balloon to inflate the pericardial balloon.
 4. Thedevice of claim 1, wherein the at least two electromagnetic plates areoperable to expand the bladder, wherein the expansion of the bladderremoves gas from the first pericardial balloon to deflate thepericardial balloon.
 5. The device of claim 1, wherein gas enters thefirst pericardial balloon from the bladder, through the lumen of the atleast one catheter, and out from the at least one aperture definedwithin the at least one catheter.
 6. The device of claim 1, wherein gasis removed from the first pericardial balloon through the at least oneaperture defined within the at least one catheter, through the lumen ofthe at least one catheter, and into the bladder.
 7. The device of claim2, wherein the distal end of the at least one catheter is adapted to bepositioned within the pericardial space at or near a heart chamber andis configured to exert pressure on an epicardial wall when inflated andis further configured to relieve pressure on the epicardial wall whendeflated in order to facilitate heart function.
 8. The device of claim7, wherein the distal end of the at least one catheter is adapted to bepositioned within the pericardial space at or near a heart ventricle. 9.The device of claim 1, wherein the at least one catheter comprises afirst catheter and a second catheter.
 10. The device of claim 9, whereinthe distal end of the first catheter is adapted to be positioned withina pericardial space at or near a first heart chamber and the distal endof the second catheter having a second pericardial balloon coupledthereto is adapted to be positioned within the pericardial space at ornear a second heart chamber, and wherein the first and second cathetersare configured to exert pressure on an epicardial wall when inflated andare further configured to relieve pressure on the epicardial wall whendeflated in order to facilitate heart function.
 11. The device of claim10, wherein inflation and deflation of the first pericardial balloonoccurs during the times of inflation and deflation, respectively, of thesecond pericardial balloon.
 12. The device of claim 11, wherein theinflation and deflation of the first and second pericardial balloonscreate a counterpulsation.
 13. The device of claim 10, wherein inflationand deflation of the first pericardial balloon occurs at a differenttimes than the times of inflation and deflation, respectively, of thesecond pericardial balloon.
 14. The device of claim 10, wherein thedistal end of the first catheter is adapted to be positioned within thepericardial space at or near a left ventricle, and wherein the distalend of the second catheter is adapted to be positioned within thepericardial space at or near a right ventricle.
 15. The device of claim1, wherein the at least one catheter comprises three or more catheters.16. The device of claim 1, wherein the first pericardial balloon is madeof polyurethane.
 17. The device of claim 1, wherein the firstpericardial balloon has an inflation volume between 30 and 40 cubiccentimeters.
 18. A device for assisting heart function, comprising: atleast two electromagnetic plates, the at least two electromagneticplates having an inner surface; a cardiac processor electrically coupledto at least one of the at least two electromagnetic plates; a bladderhaving an inner chamber, the bladder attached to the inner surfaces ofeach of the at least two electromagnetic plates and disposed between theat least two electromagnetic plates; a source of gas in communicationwith the inner chamber of the bladder; and at least one catheter havinga proximal end and a distal end and having a lumen therethrough, the atleast one catheter defining at least one aperture positionedtherethrough at or near the distal end of the at least one catheter andcomprising a pericardial balloon coupled to the at least one catheter ator near the distal end of the at least one catheter, the proximal end ofthe at least one catheter in communication with the inner chamber of thebladder; wherein the at least two electromagnetic plates are operable tocompress the bladder to inject gas into the pericardial balloon toinflate the pericardial balloon; and wherein the at least twoelectromagnetic plates are further operable to expand the bladder toremove gas from the pericardial balloon to deflate the pericardialballoon.
 19. A method of assisting heart function, the method comprisingthe steps of: introducing at least part of a device for assisting heartfunction into a mammalian body, the device comprising: at least twoelectromagnetic plates, the at least two electromagnetic plates havingan inner surface, a cardiac processor electrically coupled to at leastone of the at least two electromagnetic plates, a bladder having aninner chamber, the bladder attached to the inner surfaces of each of theat least two electromagnetic plates and disposed between the at leasttwo electromagnetic plates, a source of gas in communication with theinner chamber of the bladder, and at least one catheter having aproximal end and a distal end and having a lumen therethrough, the atleast one catheter defining at least one aperture positionedtherethrough at or near the distal end of the at least one catheter andcomprising a first pericardial balloon coupled to the at least onecatheter at or near the distal end of the at least one catheter, theproximal end of the at least one catheter in communication with theinner chamber of the bladder, wherein the distal end of the at least onecatheter is positioned within a pericardial space of the mammalian body;and operating the device to inject gas into and/or remove gas from thefirst pericardial balloon to assist heart function.
 20. The method ofclaim 19, wherein the at least two electromagnetic plates are operableto compress the bladder, wherein the compression of the bladder injectsgas into the first pericardial balloon to inflate the first pericardialballoon.
 21. The method of claim 19, wherein the at least twoelectromagnetic plates are operable to expand the bladder, wherein theexpansion of the bladder removes gas from the first pericardial balloonto deflate the first pericardial balloon.
 22. The method of claim 19,wherein gas enters the first pericardial balloon from the bladder,through the lumen of the at least one catheter, and out from the atleast one aperture defined within the at least one catheter.
 23. Themethod of claim 19, wherein gas is removed from the first pericardialballoon through the at least one aperture defined within the at leastone catheter, through the lumen of the at least one catheter, and intothe bladder.
 24. The method of claim 19, wherein when the distal end ofthe at least one catheter is positioned within the pericardial space ator near a heart chamber, inflation of the first pericardial balloonexerts pressure on an epicardial wall surrounding the heart chamber, anddeflation of the pericardial balloon relieves pressure on the epicardialwall, the inflation and deflation of the pericardial balloon operable tofacilitate heart function.
 25. The method of claim 24, wherein the heartchamber is a heart ventricle.
 26. The method of claim 19, wherein the atleast one catheter comprises a first catheter and a second catheter. 27.The method of claim 26, wherein when the distal end of the firstcatheter is positioned within the pericardial space at or near a firstheart chamber, and wherein when the distal end of the second catheterhaving a second pericardial balloon coupled thereto is positioned withinthe pericardial space at or near a second heart chamber, inflation ofthe first and second pericardial balloons exerts pressure on anepicardial wall surrounding the first heart chamber and the second heartchamber, and deflation of the first and second pericardial balloonsrelieves pressure on the epicardial wall, the inflation and deflation ofthe first and second pericardial balloons operable to facilitate heartfunction.
 28. The method of claim 27, wherein inflation and deflation ofthe first pericardial balloon occurs during the times of inflation anddeflation, respectively, of the second pericardial balloon.
 29. Themethod of claim 28, wherein the inflation and deflation of the first andsecond pericardial balloons create a counterpulsation.
 30. The method ofclaim 27, wherein inflation and deflation of the first pericardialballoon occurs at a different times than the times of inflation anddeflation, respectively, of the second pericardial balloon.
 31. Themethod of claim 27, wherein the first heart chamber is a left ventricle,and wherein the second heart chamber is a right ventricle.